Dan Stewart - Academia.edu (original) (raw)
Papers by Dan Stewart
Pediatrics, Jan 31, 2015
The anticipated birth of an extremely low gestational age (<25 weeks) infant presents many dif... more The anticipated birth of an extremely low gestational age (<25 weeks) infant presents many difficult questions, and variations in practice continue to exist. Decisions regarding care of periviable infants should ideally be well informed, ethically sound, consistent within medical teams, and consonant with the parents' wishes. Each health care institution should consider having policies and procedures for antenatal counseling in these situations. Family counseling may be aided by the use of visual materials, which should take into consideration the intellectual, cultural, and other characteristics of the family members. Although general recommendations can guide practice, each situation is unique; thus, decision-making should be individualized. In most cases, the approach should be shared decision-making with the family, guided by considering both the likelihood of death or morbidity and the parents' desires for their unborn child. If a decision is made not to resuscitate,...
Clinical Epidemiology, 2011
Digestive Diseases and Sciences, Jul 7, 2010
Limited data on proton pump inhibitors in infants led regulatory agencies to request sponsors to ... more Limited data on proton pump inhibitors in infants led regulatory agencies to request sponsors to conduct pediatric studies. To determine the pharmacodynamic response to pantoprazole in infants with GERD to aid the dose selection for an efficacy study. In two open-label studies, neonates and preterm infants (study 1, ~1.2 mg/kg [high dose]) and infants 1 through 11 months (study 2, ~0.6 [low dose] or ~1.2 mg/kg [high dose]) received once-daily pantoprazole. Twenty-four-hour dual-electrode pH-metry parameters were compared between predose and steady state (≥5 days) (two-sided paired t test). Treatment was administered for ≤6 weeks. In studies 1 and 2, 21 and 24 patients, respectively, were enrolled for pharmacodynamic evaluation. The high dose provided similar responses in the two studies and improved these parameters significantly: mean gastric pH and percent time gastric pH &amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;gt; 4 increased (p &amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;lt; 0.05 both studies), normalized area under the curve (AUC) of gastric H(+) activity decreased (p &amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;lt; 0.05 study 2), and normalized AUC of esophageal H(+) activity decreased (p &amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;lt; 0.05 both studies). The AUC of esophageal pH &amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;lt; 4 decreased. Normalized AUC of esophageal H(+) activity decreased (p &amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;lt; 0.05 both studies), indicating refluxate pH increased, although this was not reflected in any change in mean esophageal pH or reflux index. The normalized AUC of esophageal H(+) activity was a more sensitive measure of changes in esophageal pH. In neonates, preterm infants, and infants aged 1 through 11 months, pantoprazole (high dose) improved pH-metry parameters after ≥5 consecutive daily doses, and was generally well tolerated for ≤6 weeks.
CPT: pharmacometrics & systems pharmacology, May 22, 2019
Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, Jan 13, 2016
Invasive candidiasis (IC) is an important cause of sepsis in premature infants and is associated... more Invasive candidiasis (IC) is an important cause of sepsis in premature infants and is associated with a high risk of death and neurodevelopmental impairment. Prevention of IC has become a major focus in very low birth weight infants with fluconazole increasingly used as prophylaxis. We identified all randomized, placebo-controlled trials evaluating fluconazole prophylaxis in premature infants conducted in the United States. We obtained patient-level data from the study investigators and performed an aggregated analysis. The occurrence of each endpoint in infants who received prophylaxis with fluconazole versus placebo was compared. Endpoints evaluated were IC or death, IC, death, Candida colonization, and fluconazole resistance among tested isolates. Safety endpoints evaluated included clinical and laboratory parameters. Fluconazole prophylaxis reduced the odds of IC or death, IC, and Candida colonization during the drug exposure period compared to infants given placebo, OR=0.48 ...
Pediatrics, 1992
To the Editor.— Dr Hocker and his colleagues1 are to be commended for taking on the difficult tas... more To the Editor.— Dr Hocker and his colleagues1 are to be commended for taking on the difficult task of evaluating the success of ECMO in early-onset group B streptococcal infection when a controlled trial is ethically and practically not feasible. In their study they used historical controls (a commonly criticized method, but all that is realistically available) to identify risk factors for early-onset group B streptococcal sepsis and to evaluate the effectiveness of ECMO intervention.
Pediatrics, 2017
Disasters disproportionally affect vulnerable, technology-dependent people, including preterm and... more Disasters disproportionally affect vulnerable, technology-dependent people, including preterm and critically ill newborn infants. It is important for health care providers to be aware of and prepared for the potential consequences of disasters for the NICU. Neonatal intensive care personnel can provide specialized expertise for their hospital, community, and regional emergency preparedness plans and can help develop institutional surge capacity for mass critical care, including equipment, medications, personnel, and facility resources.
Clinical Pediatrics, 2001
To the editor: Premature neonates may suffer esophageal perforation as a result of unsuccessful a... more To the editor: Premature neonates may suffer esophageal perforation as a result of unsuccessful attempts at endotracheal intubation or passage of a feeding tube or suction catheter.'-3 The most common site for iatrogenic neonatal esophageal perforation is in the upper esophagus at the pyriform sinus or posterior esophagus above the cricopharyngeus.4 We present an unusual case of perforation occurring in the distal esophagus, just above the gastroesophageal junction. A female infant born at 25 weeks estimated gestational age and weighing 830 grams was evaluated at 15 days of age with an upper gastrointestinal series after a 10-French replogle catheter could not be passed into the stomach for decompression (see Fig-
Pediatrics
Point-of-care ultrasonography (POCUS) refers to the use of portable imaging performed by the prov... more Point-of-care ultrasonography (POCUS) refers to the use of portable imaging performed by the provider clinician at the bedside for diagnostic, therapeutic, and procedural purposes. POCUS could be considered an extension of the physical examination but not a substitute for diagnostic imaging. Use of POCUS in emergency situations can be lifesaving in the NICU if performed in a timely fashion for cardiac tamponade, pleural effusions, pneumothorax, etc, with potential for enhancing quality of care and improving outcomes. In the past 2 decades, POCUS has gained significant acceptance in clinical medicine in many parts of the world and in many subspecialties. Formal accredited training and certification programs are available for neonatology trainees as well as for many other subspecialties in Canada, Australia, and New Zealand. Although no formal training program or certification is available to neonatologists in Europe, POCUS is widely available to providers in NICUs. A formal instituti...
Journal of Perinatology, 2021
Objective To evaluate the efficacy and safety of tin mesoporphyrin (SnMP) in neonates with hyperb... more Objective To evaluate the efficacy and safety of tin mesoporphyrin (SnMP) in neonates with hyperbilirubinemia (HB) due to hemolysis. Study Design This multicenter, placebo-controlled phase 2b study (NCT01887327) randomized newborns (35–42 weeks) with hemolysis started on phototherapy (PT) to placebo (Ctrl), SnMP 3.0 mg/kg, or SnMP 4.5 mg/kg given once IM within 30 min of initiation of PT. Results In all, 91 patients were randomized (Ctrl: n = 30; 3 mg/kg SnMP: n = 30; 4.5 mg/kg SnMP: n = 31). At 48 h TSB significantly increased in Ctrl by 17.5% (95% CI 5.6–30.7; p = 0.004) and significantly decreased by −13% (95% CI −21.7 to −3.2; p = 0.013) in the 3.0 mg/kg and by −10.5% (95% CI −19.4 to −0.6; p = 0.041) in the 4.5 mg/kg group. Decreases in SnMP groups were significant ( p < 0.0001) vs Ctrl. Conclusion SnMP with PT significantly reduced TSB by 48 h. SnMP may be useful as a treatment for HB in neonates with hemolysis.
Archives of disease in childhood. Education and practice edition, Jan 19, 2017
Neonates, especially preterm infants, are often subjected to frequent painful procedures during t... more Neonates, especially preterm infants, are often subjected to frequent painful procedures during their stay in the neonatal intensive care unit.1 Repeated painful stimuli in early life are known to result in both short-term and long-term sequelae. These include physiological instability, abnormal somatosensory and stress responses, and effects on long-term neurodevelopment, behavioural and social-emotional outcomes.2 3 The management of pain in a neonate is also challenging because neonates are unable to report pain, and it can be particularly difficult to assess pain in the extreme preterm, ill or neurologically compromised neonate. Therefore, it is important that all healthcare professionals who are involved in the care of these infants are aware of how to assess pain and stress, and manage pain appropriately. In February 2016, the American Academy of Pediatrics (AAP) published an updated guideline entitled ‘Prevention and management of procedural pain in the neonate’.4 The guideline development group included representatives from the AAP Committee of Fetus and Newborn, 2015–2016, and Section on Anesthesiology and Pain Medicine Executive Committee, 2014–2015. The previous guideline on the management and prevention of procedural pain in the neonate was published by the AAP in 2007. This revision updates previous recommendations with new evidence to aid healthcare professionals to ‘implement a pain assessment and management plan for the prevention of pain associated with routine minor procedures, and with surgery and other major procedures in neonates.’
The Journal of the Kentucky Medical Association, Nov 1, 1994
Pediatrics, 2020
The American Academy of Pediatrics (AAP) believes that current data show that hospitals and accre... more The American Academy of Pediatrics (AAP) believes that current data show that hospitals and accredited birth centers are the safest settings for birth in the United States. The AAP does not recommend planned home birth, which has been reported to be associated with a twofold to threefold increase in infant mortality in the United States. The AAP recognizes that women may choose to plan a home birth. This statement is intended to help pediatricians provide constructive, informed counsel to women considering home birth while retaining their role as child advocates and to summarize appropriate care for newborn infants born at home that is consistent with care provided for infants born in a medical care facility. Regardless of the circumstances of his or her birth, including location, every newborn infant deserves health care consistent with that highlighted in this statement, which is more completely described in other publications from the AAP, including Guidelines for Perinatal Care ...
Journal of Perinatology, 2021
Pediatrics, 2019
Group B streptococcal (GBS) infection remains the most common cause of neonatal early-onset sepsi... more Group B streptococcal (GBS) infection remains the most common cause of neonatal early-onset sepsis and a significant cause of late-onset sepsis among young infants. Administration of intrapartum antibiotic prophylaxis is the only currently available effective strategy for the prevention of perinatal GBS early-onset disease, and there is no effective approach for the prevention of late-onset disease. The American Academy of Pediatrics joins with the American College of Obstetricians and Gynecologists to reaffirm the use of universal antenatal microbiologic-based testing for the detection of maternal GBS colonization to facilitate appropriate administration of intrapartum antibiotic prophylaxis. The purpose of this clinical report is to provide neonatal clinicians with updated information regarding the epidemiology of GBS disease as well current recommendations for the evaluation of newborn infants at risk for GBS disease and for treatment of those with confirmed GBS infection. This c...
Pediatrics, Jan 31, 2015
The anticipated birth of an extremely low gestational age (<25 weeks) infant presents many dif... more The anticipated birth of an extremely low gestational age (<25 weeks) infant presents many difficult questions, and variations in practice continue to exist. Decisions regarding care of periviable infants should ideally be well informed, ethically sound, consistent within medical teams, and consonant with the parents' wishes. Each health care institution should consider having policies and procedures for antenatal counseling in these situations. Family counseling may be aided by the use of visual materials, which should take into consideration the intellectual, cultural, and other characteristics of the family members. Although general recommendations can guide practice, each situation is unique; thus, decision-making should be individualized. In most cases, the approach should be shared decision-making with the family, guided by considering both the likelihood of death or morbidity and the parents' desires for their unborn child. If a decision is made not to resuscitate,...
Clinical Epidemiology, 2011
Digestive Diseases and Sciences, Jul 7, 2010
Limited data on proton pump inhibitors in infants led regulatory agencies to request sponsors to ... more Limited data on proton pump inhibitors in infants led regulatory agencies to request sponsors to conduct pediatric studies. To determine the pharmacodynamic response to pantoprazole in infants with GERD to aid the dose selection for an efficacy study. In two open-label studies, neonates and preterm infants (study 1, ~1.2 mg/kg [high dose]) and infants 1 through 11 months (study 2, ~0.6 [low dose] or ~1.2 mg/kg [high dose]) received once-daily pantoprazole. Twenty-four-hour dual-electrode pH-metry parameters were compared between predose and steady state (≥5 days) (two-sided paired t test). Treatment was administered for ≤6 weeks. In studies 1 and 2, 21 and 24 patients, respectively, were enrolled for pharmacodynamic evaluation. The high dose provided similar responses in the two studies and improved these parameters significantly: mean gastric pH and percent time gastric pH &amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;gt; 4 increased (p &amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;lt; 0.05 both studies), normalized area under the curve (AUC) of gastric H(+) activity decreased (p &amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;lt; 0.05 study 2), and normalized AUC of esophageal H(+) activity decreased (p &amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;lt; 0.05 both studies). The AUC of esophageal pH &amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;lt; 4 decreased. Normalized AUC of esophageal H(+) activity decreased (p &amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;lt; 0.05 both studies), indicating refluxate pH increased, although this was not reflected in any change in mean esophageal pH or reflux index. The normalized AUC of esophageal H(+) activity was a more sensitive measure of changes in esophageal pH. In neonates, preterm infants, and infants aged 1 through 11 months, pantoprazole (high dose) improved pH-metry parameters after ≥5 consecutive daily doses, and was generally well tolerated for ≤6 weeks.
CPT: pharmacometrics & systems pharmacology, May 22, 2019
Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, Jan 13, 2016
Invasive candidiasis (IC) is an important cause of sepsis in premature infants and is associated... more Invasive candidiasis (IC) is an important cause of sepsis in premature infants and is associated with a high risk of death and neurodevelopmental impairment. Prevention of IC has become a major focus in very low birth weight infants with fluconazole increasingly used as prophylaxis. We identified all randomized, placebo-controlled trials evaluating fluconazole prophylaxis in premature infants conducted in the United States. We obtained patient-level data from the study investigators and performed an aggregated analysis. The occurrence of each endpoint in infants who received prophylaxis with fluconazole versus placebo was compared. Endpoints evaluated were IC or death, IC, death, Candida colonization, and fluconazole resistance among tested isolates. Safety endpoints evaluated included clinical and laboratory parameters. Fluconazole prophylaxis reduced the odds of IC or death, IC, and Candida colonization during the drug exposure period compared to infants given placebo, OR=0.48 ...
Pediatrics, 1992
To the Editor.— Dr Hocker and his colleagues1 are to be commended for taking on the difficult tas... more To the Editor.— Dr Hocker and his colleagues1 are to be commended for taking on the difficult task of evaluating the success of ECMO in early-onset group B streptococcal infection when a controlled trial is ethically and practically not feasible. In their study they used historical controls (a commonly criticized method, but all that is realistically available) to identify risk factors for early-onset group B streptococcal sepsis and to evaluate the effectiveness of ECMO intervention.
Pediatrics, 2017
Disasters disproportionally affect vulnerable, technology-dependent people, including preterm and... more Disasters disproportionally affect vulnerable, technology-dependent people, including preterm and critically ill newborn infants. It is important for health care providers to be aware of and prepared for the potential consequences of disasters for the NICU. Neonatal intensive care personnel can provide specialized expertise for their hospital, community, and regional emergency preparedness plans and can help develop institutional surge capacity for mass critical care, including equipment, medications, personnel, and facility resources.
Clinical Pediatrics, 2001
To the editor: Premature neonates may suffer esophageal perforation as a result of unsuccessful a... more To the editor: Premature neonates may suffer esophageal perforation as a result of unsuccessful attempts at endotracheal intubation or passage of a feeding tube or suction catheter.'-3 The most common site for iatrogenic neonatal esophageal perforation is in the upper esophagus at the pyriform sinus or posterior esophagus above the cricopharyngeus.4 We present an unusual case of perforation occurring in the distal esophagus, just above the gastroesophageal junction. A female infant born at 25 weeks estimated gestational age and weighing 830 grams was evaluated at 15 days of age with an upper gastrointestinal series after a 10-French replogle catheter could not be passed into the stomach for decompression (see Fig-
Pediatrics
Point-of-care ultrasonography (POCUS) refers to the use of portable imaging performed by the prov... more Point-of-care ultrasonography (POCUS) refers to the use of portable imaging performed by the provider clinician at the bedside for diagnostic, therapeutic, and procedural purposes. POCUS could be considered an extension of the physical examination but not a substitute for diagnostic imaging. Use of POCUS in emergency situations can be lifesaving in the NICU if performed in a timely fashion for cardiac tamponade, pleural effusions, pneumothorax, etc, with potential for enhancing quality of care and improving outcomes. In the past 2 decades, POCUS has gained significant acceptance in clinical medicine in many parts of the world and in many subspecialties. Formal accredited training and certification programs are available for neonatology trainees as well as for many other subspecialties in Canada, Australia, and New Zealand. Although no formal training program or certification is available to neonatologists in Europe, POCUS is widely available to providers in NICUs. A formal instituti...
Journal of Perinatology, 2021
Objective To evaluate the efficacy and safety of tin mesoporphyrin (SnMP) in neonates with hyperb... more Objective To evaluate the efficacy and safety of tin mesoporphyrin (SnMP) in neonates with hyperbilirubinemia (HB) due to hemolysis. Study Design This multicenter, placebo-controlled phase 2b study (NCT01887327) randomized newborns (35–42 weeks) with hemolysis started on phototherapy (PT) to placebo (Ctrl), SnMP 3.0 mg/kg, or SnMP 4.5 mg/kg given once IM within 30 min of initiation of PT. Results In all, 91 patients were randomized (Ctrl: n = 30; 3 mg/kg SnMP: n = 30; 4.5 mg/kg SnMP: n = 31). At 48 h TSB significantly increased in Ctrl by 17.5% (95% CI 5.6–30.7; p = 0.004) and significantly decreased by −13% (95% CI −21.7 to −3.2; p = 0.013) in the 3.0 mg/kg and by −10.5% (95% CI −19.4 to −0.6; p = 0.041) in the 4.5 mg/kg group. Decreases in SnMP groups were significant ( p < 0.0001) vs Ctrl. Conclusion SnMP with PT significantly reduced TSB by 48 h. SnMP may be useful as a treatment for HB in neonates with hemolysis.
Archives of disease in childhood. Education and practice edition, Jan 19, 2017
Neonates, especially preterm infants, are often subjected to frequent painful procedures during t... more Neonates, especially preterm infants, are often subjected to frequent painful procedures during their stay in the neonatal intensive care unit.1 Repeated painful stimuli in early life are known to result in both short-term and long-term sequelae. These include physiological instability, abnormal somatosensory and stress responses, and effects on long-term neurodevelopment, behavioural and social-emotional outcomes.2 3 The management of pain in a neonate is also challenging because neonates are unable to report pain, and it can be particularly difficult to assess pain in the extreme preterm, ill or neurologically compromised neonate. Therefore, it is important that all healthcare professionals who are involved in the care of these infants are aware of how to assess pain and stress, and manage pain appropriately. In February 2016, the American Academy of Pediatrics (AAP) published an updated guideline entitled ‘Prevention and management of procedural pain in the neonate’.4 The guideline development group included representatives from the AAP Committee of Fetus and Newborn, 2015–2016, and Section on Anesthesiology and Pain Medicine Executive Committee, 2014–2015. The previous guideline on the management and prevention of procedural pain in the neonate was published by the AAP in 2007. This revision updates previous recommendations with new evidence to aid healthcare professionals to ‘implement a pain assessment and management plan for the prevention of pain associated with routine minor procedures, and with surgery and other major procedures in neonates.’
The Journal of the Kentucky Medical Association, Nov 1, 1994
Pediatrics, 2020
The American Academy of Pediatrics (AAP) believes that current data show that hospitals and accre... more The American Academy of Pediatrics (AAP) believes that current data show that hospitals and accredited birth centers are the safest settings for birth in the United States. The AAP does not recommend planned home birth, which has been reported to be associated with a twofold to threefold increase in infant mortality in the United States. The AAP recognizes that women may choose to plan a home birth. This statement is intended to help pediatricians provide constructive, informed counsel to women considering home birth while retaining their role as child advocates and to summarize appropriate care for newborn infants born at home that is consistent with care provided for infants born in a medical care facility. Regardless of the circumstances of his or her birth, including location, every newborn infant deserves health care consistent with that highlighted in this statement, which is more completely described in other publications from the AAP, including Guidelines for Perinatal Care ...
Journal of Perinatology, 2021
Pediatrics, 2019
Group B streptococcal (GBS) infection remains the most common cause of neonatal early-onset sepsi... more Group B streptococcal (GBS) infection remains the most common cause of neonatal early-onset sepsis and a significant cause of late-onset sepsis among young infants. Administration of intrapartum antibiotic prophylaxis is the only currently available effective strategy for the prevention of perinatal GBS early-onset disease, and there is no effective approach for the prevention of late-onset disease. The American Academy of Pediatrics joins with the American College of Obstetricians and Gynecologists to reaffirm the use of universal antenatal microbiologic-based testing for the detection of maternal GBS colonization to facilitate appropriate administration of intrapartum antibiotic prophylaxis. The purpose of this clinical report is to provide neonatal clinicians with updated information regarding the epidemiology of GBS disease as well current recommendations for the evaluation of newborn infants at risk for GBS disease and for treatment of those with confirmed GBS infection. This c...