Birju A Shah | Brown University (original) (raw)

Papers by Birju A Shah

The Journal of Pediatrics, 2013

Objective To examine circulating levels of inter-alpha inhibitor protein (IaIp) in infants with n... more Objective To examine circulating levels of inter-alpha inhibitor protein (IaIp) in infants with necrotizing enteroco-litis (NEC), spontaneous intestinal perforation (SIP), and matched controls to assess the diagnostic accuracy of IaIp to differentiate NEC from SIP and to compare receiver operating characteristics of IaIp for NEC with C-reactive protein (CRP).
Study design A prospective, nested case-control study of infants with feeding intolerance was carried out. Blood and clinical data were collected from 27 infants diagnosed with NEC or SIP and from 26 matched controls admitted to our unit. Infants with modified Bell criteria stage 2 or greater were included as NEC. Clinical, radiologic, and/ or surgical findings were used to identify infants with SIP. Controls were matched for gestational age, postnatal age, sex, and birth weight.
Results Mean ± SD IaIp blood levels were 147 ± 38 mg/L, 276 ± 67 mg/L, and 330 ± 100 mg/L in infants with NEC, SIP, and matched controls, respectively (P < .004 and P < .01). Receiver operating characteristics analysis to establish the predictive value of NEC demonstrated areas under curve of 0.98 and 0.63 for IaIp and CRP, respectively.
Conclusions IaIp levels were significantly decreased in infants with NEC compared with SIP and matched controls. The diagnostic accuracy of IaIp for NEC was superior to that of CRP. (J Pediatr 2016).

IMPORTANCE: Hypothermia at 33.5°C for 72 hours for neonatal hypoxic ischemic encephalopathy redu... more IMPORTANCE:

Hypothermia at 33.5°C for 72 hours for neonatal hypoxic ischemic encephalopathy reduces death or disability to 44% to 55%; longer cooling and deeper cooling are neuroprotective in animal models.

OBJECTIVE:

To determine if longer duration cooling (120 hours), deeper cooling (32.0°C), or both are superior to cooling at 33.5°C for 72 hours in neonates who are full-term with moderate or severe hypoxic ischemic encephalopathy.

DESIGN, SETTING, AND PARTICIPANTS:

A randomized, 2 × 2 factorial design clinical trial performed in 18 US centers in the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Neonatal Research Network between October 2010 and November 2013.

INTERVENTIONS:

Neonates were assigned to 4 hypothermia groups; 33.5°C for 72 hours, 32.0°C for 72 hours, 33.5°C for 120 hours, and 32.0°C for 120 hours.

MAIN OUTCOMES AND MEASURES:

The primary outcome of death or disability at 18 to 22 months is ongoing. The independent data and safety monitoring committee paused the trial to evaluate safety (cardiac arrhythmia, persistent acidosis, major vessel thrombosis and bleeding, and death in the neonatal intensive care unit [NICU]) after the first 50 neonates were enrolled, then after every subsequent 25 neonates. The trial was closed for emerging safety profile and futility analysis after the eighth review with 364 neonates enrolled (of 726 planned). This report focuses on safety and NICU deaths by marginal comparisons of 72 hours' vs 120 hours' duration and 33.5°C depth vs 32.0°C depth (predefined secondary outcomes).

RESULTS:

The NICU death rates were 7 of 95 neonates (7%) for the 33.5°C for 72 hours group, 13 of 90 neonates (14%) for the 32.0°C for 72 hours group, 15 of 96 neonates (16%) for the 33.5°C for 120 hours group, and 14 of 83 neonates (17%) for the 32.0°C for 120 hours group. The adjusted risk ratio (RR) for NICU deaths for the 120 hours group vs 72 hours group was 1.37 (95% CI, 0.92-2.04) and for the 32.0°C group vs 33.5°C group was 1.24 (95% CI, 0.69-2.25). Safety outcomes were similar between the 120 hours group vs 72 hours group and the 32.0°C group vs 33.5°C group, except major bleeding occurred among 1% in the 120 hours group vs 3% in the 72 hours group (RR, 0.25 [95% CI, 0.07-0.91]). Futility analysis determined that the probability of detecting a statistically significant benefit for longer cooling, deeper cooling, or both for NICU death was less than 2%.

CONCLUSIONS AND RELEVANCE:

Among neonates who were full-term with moderate or severe hypoxic ischemic encephalopathy, longer cooling, deeper cooling, or both compared with hypothermia at 33.5°C for 72 hours did not reduce NICU death. These results have implications for patient care and design of future trials.

intra-and interobserver variability and accuracy. Pediatr Radiol 2006;36: 43-9. 24. Berger MY, Ta... more intra-and interobserver variability and accuracy. Pediatr Radiol 2006;36: 43-9. 24. Berger MY, Tabbers MM, Kurver MJ, Boluyt N, Benninga MA. Value of abdominal radiography, colonic transit time, and rectal ultrasound scanning in the diagnosis of idiopathic constipation in children: a systematic review. J Pediatr 2012;161:44-50.e1-2. 25. Arnbjornsson E. Acute appendicitis related to faecal stasis. Ann Chir Gynaecol 1985;74:90-3. 26. Campbell JP, Gunn AA. Plain abdominal radiographs and acute abdominal pain. Br J Surg 1988;75:554-6. 27. Rothrock SG, Green SM, Hummel CB. Plain abdominal radiography in the detection of major disease in children: a prospective analysis. Ann

The Journal of Pediatrics, 2013

Objective To examine circulating levels of inter-alpha inhibitor protein (IaIp) in infants with n... more Objective To examine circulating levels of inter-alpha inhibitor protein (IaIp) in infants with necrotizing enteroco-litis (NEC), spontaneous intestinal perforation (SIP), and matched controls to assess the diagnostic accuracy of IaIp to differentiate NEC from SIP and to compare receiver operating characteristics of IaIp for NEC with C-reactive protein (CRP).
Study design A prospective, nested case-control study of infants with feeding intolerance was carried out. Blood and clinical data were collected from 27 infants diagnosed with NEC or SIP and from 26 matched controls admitted to our unit. Infants with modified Bell criteria stage 2 or greater were included as NEC. Clinical, radiologic, and/ or surgical findings were used to identify infants with SIP. Controls were matched for gestational age, postnatal age, sex, and birth weight.
Results Mean ± SD IaIp blood levels were 147 ± 38 mg/L, 276 ± 67 mg/L, and 330 ± 100 mg/L in infants with NEC, SIP, and matched controls, respectively (P < .004 and P < .01). Receiver operating characteristics analysis to establish the predictive value of NEC demonstrated areas under curve of 0.98 and 0.63 for IaIp and CRP, respectively.
Conclusions IaIp levels were significantly decreased in infants with NEC compared with SIP and matched controls. The diagnostic accuracy of IaIp for NEC was superior to that of CRP. (J Pediatr 2016).

IMPORTANCE: Hypothermia at 33.5°C for 72 hours for neonatal hypoxic ischemic encephalopathy redu... more IMPORTANCE:

Hypothermia at 33.5°C for 72 hours for neonatal hypoxic ischemic encephalopathy reduces death or disability to 44% to 55%; longer cooling and deeper cooling are neuroprotective in animal models.

OBJECTIVE:

To determine if longer duration cooling (120 hours), deeper cooling (32.0°C), or both are superior to cooling at 33.5°C for 72 hours in neonates who are full-term with moderate or severe hypoxic ischemic encephalopathy.

DESIGN, SETTING, AND PARTICIPANTS:

A randomized, 2 × 2 factorial design clinical trial performed in 18 US centers in the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Neonatal Research Network between October 2010 and November 2013.

INTERVENTIONS:

Neonates were assigned to 4 hypothermia groups; 33.5°C for 72 hours, 32.0°C for 72 hours, 33.5°C for 120 hours, and 32.0°C for 120 hours.

MAIN OUTCOMES AND MEASURES:

The primary outcome of death or disability at 18 to 22 months is ongoing. The independent data and safety monitoring committee paused the trial to evaluate safety (cardiac arrhythmia, persistent acidosis, major vessel thrombosis and bleeding, and death in the neonatal intensive care unit [NICU]) after the first 50 neonates were enrolled, then after every subsequent 25 neonates. The trial was closed for emerging safety profile and futility analysis after the eighth review with 364 neonates enrolled (of 726 planned). This report focuses on safety and NICU deaths by marginal comparisons of 72 hours' vs 120 hours' duration and 33.5°C depth vs 32.0°C depth (predefined secondary outcomes).

RESULTS:

The NICU death rates were 7 of 95 neonates (7%) for the 33.5°C for 72 hours group, 13 of 90 neonates (14%) for the 32.0°C for 72 hours group, 15 of 96 neonates (16%) for the 33.5°C for 120 hours group, and 14 of 83 neonates (17%) for the 32.0°C for 120 hours group. The adjusted risk ratio (RR) for NICU deaths for the 120 hours group vs 72 hours group was 1.37 (95% CI, 0.92-2.04) and for the 32.0°C group vs 33.5°C group was 1.24 (95% CI, 0.69-2.25). Safety outcomes were similar between the 120 hours group vs 72 hours group and the 32.0°C group vs 33.5°C group, except major bleeding occurred among 1% in the 120 hours group vs 3% in the 72 hours group (RR, 0.25 [95% CI, 0.07-0.91]). Futility analysis determined that the probability of detecting a statistically significant benefit for longer cooling, deeper cooling, or both for NICU death was less than 2%.

CONCLUSIONS AND RELEVANCE:

Among neonates who were full-term with moderate or severe hypoxic ischemic encephalopathy, longer cooling, deeper cooling, or both compared with hypothermia at 33.5°C for 72 hours did not reduce NICU death. These results have implications for patient care and design of future trials.

intra-and interobserver variability and accuracy. Pediatr Radiol 2006;36: 43-9. 24. Berger MY, Ta... more intra-and interobserver variability and accuracy. Pediatr Radiol 2006;36: 43-9. 24. Berger MY, Tabbers MM, Kurver MJ, Boluyt N, Benninga MA. Value of abdominal radiography, colonic transit time, and rectal ultrasound scanning in the diagnosis of idiopathic constipation in children: a systematic review. J Pediatr 2012;161:44-50.e1-2. 25. Arnbjornsson E. Acute appendicitis related to faecal stasis. Ann Chir Gynaecol 1985;74:90-3. 26. Campbell JP, Gunn AA. Plain abdominal radiographs and acute abdominal pain. Br J Surg 1988;75:554-6. 27. Rothrock SG, Green SM, Hummel CB. Plain abdominal radiography in the detection of major disease in children: a prospective analysis. Ann