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Infant well‐being at 2 years of age in the Growth Restriction Intervention Trial (GRIT): multicentred randomized controlled trial
Author(s) -
Reading Richard
Publication year - 2004
Publication title -
child: care, health and development
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.832
H-Index - 82
eISSN - 1365-2214
pISSN - 0305-1862
DOI - 10.1111/j.1365-2214.2004.00483_6.x
Subject(s) - medicine , randomized controlled trial , gestational age , randomization , pediatrics , odds ratio , gestation , pregnancy , obstetrics , surgery , biology , genetics
Infant well‐being at 2 years of age in the Growth Restriction Intervention Trial (GRIT): multicentred randomized controlled trial.
The GRIT study group(2004)Lancet,364,513–520.Background Although delivery is widely used for preterm babies failing to thrive in utero , the effect of altering delivery timing has never been assessed in a randomized controlled trial. We aimed to compare the effect of delivering early with delaying birth for as long as possible. Methods Five hundred and forty‐eight pregnant women were recruited by 69 hospitals in 13 European countries. Participants had fetal compromise between 24 and 36 weeks, an umbilical‐artery Doppler waveform recorded, and clinical uncertainty about whether immediate delivery was indicated. Before birth, 588 babies were randomly assigned to immediate delivery ( n = 296) or delayed delivery until the obstetrician was no longer uncertain ( n = 292). The main outcome was death or disability at or beyond 2 years of age. Disability was defined as a Griffiths developmental quotient of 70 or less or the presence of motor or perceptual severe disability. Analysis was by intention‐to‐treat. This trial has been assigned the International Standard Randomized Controlled Trial Number ISRCTN41358726. Findings Primary outcomes were available on 290 (98%) immediate and 283 (97%) deferred deliveries. Overall rate of death or severe disability at 2 years was 55 (19%) of 290 immediate births, and 44 (16%) of 283 delayed births. With adjustment for gestational age and umbilical‐artery Doppler category, the odds ratio (95% CrI) was 1.1 (0.7–1.8). Most of the observed difference was in disability in babies younger than 31 weeks of gestation at randomization: 14 (13%) immediate vs. five (5%) delayed deliveries. No important differences in the median Griffiths developmental quotient in survivors was seen. Interpretation The lack of difference in mortality suggests that obstetricians are delivering sick preterm babies at about the correct moment to minimize mortality. However, they could be delivering too early to minimize brain damage. These results do not lend support to the idea that obstetricians can deliver before terminal hypoxaemia to improve brain development.