Caroline C Marrs1, Hector Mendez-Figueroa1, Ibrahim A Hammad2, Suneet P Chauhan1. 1. Division of Maternal-Fetal Medicine, Department of Obstetrics, Gynecology, and Reproductive Sciences, UT Health Science Center at Houston, Houston, Texas. 2. Department of Obstetrics-Gynecology, Eastern Virginia Medical School, Norfolk, Virginia.
Abstract
OBJECTIVE: The objective of this study was to determine the morbidity of preterm small for gestational age (SGA) infants compared with appropriate for GA (AGA). STUDY DESIGN: This is a secondary analysis of the randomized trial evaluating magnesium sulfate for the prevention of cerebral palsy (CP). We compared outcomes of preterm (< 37 weeks) nonanomalous infants who were SGA (birth weight < 10% for GA) versus AGA (birth weight 10-89% for GA). We compared (1) the parent trial primary outcome, a composite of stillbirth, infant death by 1 year of age, or moderate to severe CP at 2 years of age and (2) composite neonatal morbidity (CNM). RESULTS: Of the 1,948 infants who met inclusion criteria, 95% were AGA and 5% were SGA. The primary outcome was similar (10 and 15%, p = 0.08), as was the CNM (24 and 25%, p = 0.89). Sample size calculations indicate that detection of a one-third higher rate of CNM among SGA compared with AGA infants requires more than 93,900 preterm births; for a one-third difference in moderate to severe CP, more than 1.4 million infants. CONCLUSION: Owing to the prohibitive sample size required, ascertaining a difference in sequela between preterm SGA and AGA infants is possibly unverifiable. Thieme Medical Publishers 333 Seventh Avenue, New York, NY 10001, USA.
RCT Entities:
OBJECTIVE: The objective of this study was to determine the morbidity of preterm small for gestational age (SGA) infants compared with appropriate for GA (AGA). STUDY DESIGN: This is a secondary analysis of the randomized trial evaluating magnesium sulfate for the prevention of cerebral palsy (CP). We compared outcomes of preterm (< 37 weeks) nonanomalous infants who were SGA (birth weight < 10% for GA) versus AGA (birth weight 10-89% for GA). We compared (1) the parent trial primary outcome, a composite of stillbirth, infant death by 1 year of age, or moderate to severe CP at 2 years of age and (2) composite neonatal morbidity (CNM). RESULTS: Of the 1,948 infants who met inclusion criteria, 95% were AGA and 5% were SGA. The primary outcome was similar (10 and 15%, p = 0.08), as was the CNM (24 and 25%, p = 0.89). Sample size calculations indicate that detection of a one-third higher rate of CNM among SGA compared with AGA infants requires more than 93,900 preterm births; for a one-third difference in moderate to severe CP, more than 1.4 million infants. CONCLUSION: Owing to the prohibitive sample size required, ascertaining a difference in sequela between preterm SGA and AGA infants is possibly unverifiable. Thieme Medical Publishers 333 Seventh Avenue, New York, NY 10001, USA.