BACKGROUND AND OBJECTIVE: The Surfactant Positive Airway Pressure and Pulse Oximetry Randomized Trial (SUPPORT) antenatal consent study demonstrated that mothers of infants enrolled in the SUPPORT trial had significantly different demographics and exposure to antenatal steroids compared with mothers of eligible, but not enrolled infants. The objective of this analysis was to compare the outcomes of bronchopulmonary dysplasia, severe retinopathy of prematurity, severe intraventricular hemorrhage or periventricular leukomalacia (IVH/PVL), death, and death/severe IVH/PVL for infants enrolled in SUPPORT in comparison with eligible, but not enrolled infants. METHODS: Perinatal characteristics and neonatal outcomes were compared for enrolled and eligible but not enrolled infants in bivariate analyses. Models were created to test the effect of enrollment in SUPPORT on outcomes, controlling for perinatal characteristics. RESULTS: There were 1316 infants enrolled in SUPPORT; 3053 infants were eligible, but not enrolled. In unadjusted analyses, enrolled infants had significantly lower rates of death before discharge, severe IVH/PVL, death/severe IVH/PVL (all < 0.001), and bronchopulmonary dysplasia (P = .003) in comparison with eligible, but not enrolled infants. The rate of severe retinopathy of prematurity was not significantly different. After adjustment for perinatal factors, enrollment in the trial was not a significant predictor of any of the tested clinical outcomes. CONCLUSIONS: The results of this analysis demonstrate significant outcome differences between enrolled and eligible but not enrolled infants in a trial using antenatal consent, which were likely due to enrollment bias resulting from the antenatal consent process. Additional research and regulatory review need to be conducted to ensure that large moderate-risk trials that require antenatal consent can be conducted in such a way as to ensure the generalizability of results.
RCT Entities:
BACKGROUND AND OBJECTIVE: The Surfactant Positive Airway Pressure and Pulse Oximetry Randomized Trial (SUPPORT) antenatal consent study demonstrated that mothers of infants enrolled in the SUPPORT trial had significantly different demographics and exposure to antenatal steroids compared with mothers of eligible, but not enrolled infants. The objective of this analysis was to compare the outcomes of bronchopulmonary dysplasia, severe retinopathy of prematurity, severe intraventricular hemorrhage or periventricular leukomalacia (IVH/PVL), death, and death/severe IVH/PVL for infants enrolled in SUPPORT in comparison with eligible, but not enrolled infants. METHODS: Perinatal characteristics and neonatal outcomes were compared for enrolled and eligible but not enrolled infants in bivariate analyses. Models were created to test the effect of enrollment in SUPPORT on outcomes, controlling for perinatal characteristics. RESULTS: There were 1316 infants enrolled in SUPPORT; 3053 infants were eligible, but not enrolled. In unadjusted analyses, enrolled infants had significantly lower rates of death before discharge, severe IVH/PVL, death/severe IVH/PVL (all < 0.001), and bronchopulmonary dysplasia (P = .003) in comparison with eligible, but not enrolled infants. The rate of severe retinopathy of prematurity was not significantly different. After adjustment for perinatal factors, enrollment in the trial was not a significant predictor of any of the tested clinical outcomes. CONCLUSIONS: The results of this analysis demonstrate significant outcome differences between enrolled and eligible but not enrolled infants in a trial using antenatal consent, which were likely due to enrollment bias resulting from the antenatal consent process. Additional research and regulatory review need to be conducted to ensure that large moderate-risk trials that require antenatal consent can be conducted in such a way as to ensure the generalizability of results.
Authors: Wade D Rich; Kathy J Auten; Marie G Gantz; Ellen C Hale; Angelita M Hensman; Nancy S Newman; Neil N Finer Journal: Pediatrics Date: 2010-06-29 Impact factor: 7.124
Authors: S Davis; P W Wright; S F Schulman; L D Hill; R D Pinkham; L P Johnson; T W Jones; H B Kellogg; H M Radke; W W Sikkema Journal: Cancer Date: 1985-10-01 Impact factor: 6.860
Authors: Neil N Finer; Waldemar A Carlo; Michele C Walsh; Wade Rich; Marie G Gantz; Abbot R Laptook; Bradley A Yoder; Roger G Faix; Abhik Das; W Kenneth Poole; Edward F Donovan; Nancy S Newman; Namasivayam Ambalavanan; Ivan D Frantz; Susie Buchter; Pablo J Sánchez; Kathleen A Kennedy; Nirupama Laroia; Brenda B Poindexter; C Michael Cotten; Krisa P Van Meurs; Shahnaz Duara; Vivek Narendran; Beena G Sood; T Michael O'Shea; Edward F Bell; Vineet Bhandari; Kristi L Watterberg; Rosemary D Higgins Journal: N Engl J Med Date: 2010-05-16 Impact factor: 91.245
Authors: Waldemar A Carlo; Neil N Finer; Michele C Walsh; Wade Rich; Marie G Gantz; Abbot R Laptook; Bradley A Yoder; Roger G Faix; Abhik Das; W Kenneth Poole; Kurt Schibler; Nancy S Newman; Namasivayam Ambalavanan; Ivan D Frantz; Anthony J Piazza; Pablo J Sánchez; Brenda H Morris; Nirupama Laroia; Dale L Phelps; Brenda B Poindexter; C Michael Cotten; Krisa P Van Meurs; Shahnaz Duara; Vivek Narendran; Beena G Sood; T Michael O'Shea; Edward F Bell; Richard A Ehrenkranz; Kristi L Watterberg; Rosemary D Higgins Journal: N Engl J Med Date: 2010-05-16 Impact factor: 91.245
Authors: Jean R Lowe; Andrea Freeman Duncan; Carla M Bann; Janell Fuller; Susan R Hintz; Abhik Das; Rosemary D Higgins; Kristi L Watterberg Journal: Early Hum Dev Date: 2013-08-29 Impact factor: 2.079
Authors: Beau Batton; Lei Li; Nancy S Newman; Abhik Das; Kristi L Watterberg; Bradley A Yoder; Roger G Faix; Matthew M Laughon; Barbara J Stoll; Krisa P Van Meurs; Waldemar A Carlo; Brenda B Poindexter; Edward F Bell; Pablo J Sánchez; Richard A Ehrenkranz; Ronald N Goldberg; Abbot R Laptook; Kathleen A Kennedy; Ivan D Frantz; Seetha Shankaran; Kurt Schibler; Rosemary D Higgins; Michele C Walsh Journal: Pediatrics Date: 2013-05-06 Impact factor: 7.124