Key result
Integrated intervention package increases 12-month weight by ~0.22 kg vs. usual care in SGA infants.
Why the study?
Does an integrated intervention package improve weight and weight-for-age z scores at 12 months in term small-for-gestational-age infants?
RCT (n=1,300)
Single-blind
1:1
Does an integrated intervention package improve weight and weight-for-age z scores at 12 months in term small-for-gestational-age infants?
An integrated multidomain intervention significantly improved weight, growth, and neurodevelopmental outcomes at 12 months in term small-for-gestational-age infants.
Supports integrated interventions for term SGA infants in low-resource settings; extends RCT evidence on growth and neurodevelopment.
Importance: Small-for-gestational-age (SGA) infants face elevated risk of undernutrition and developmental delays. Multidomain interventions may be needed to promote growth and neurodevelopment. Objective: To evaluate the effect of an integrated intervention package on growth and neurodevelopment in term SGA infants. Design, Setting, and Participants: Individually randomized clinical trial conducted in low-resource neighborhoods of South Delhi, India. Term SGA infants were enrolled within 14 days of birth; 1300 infants were randomized and followed up to 12 months of age. Recruitment occurred from January 14, 2023, until July 31, 2024, with follow-up completed on August 6, 2025. Outcome assessors were blinded to participant allocation. Interventions: Infants were randomized in a 1:1 ratio to receive either an integrated intervention package including health, nutrition, early child stimulation, and psychosocial support (n = 647) or usual care through government programs (n = 653). Main Outcomes and Measures: The primary outcomes were weight and weight-for-age z score at 12 months. Secondary outcomes included linear growth, neurodevelopment (assessed using the Bayley Scales of Infant and Toddler Development, Third Edition), anemia, and mortality. Results: At 12 months, 1261 infants (97%) (mean age, 6 days; 48.1% male) had completed follow-up. The mean weight was 8.0 kg (SD, 0.9 kg) in the intervention group vs 7.8 kg (SD, 0.9 kg) in the usual care group (mean difference, 0.22 kg [95% CI, 0.11-0.32 kg]). The mean weight-for-age z score was -1.3 (SD, 0.9) vs -1.6 (SD, 1.0), respectively (mean difference, 0.24 [95% CI, 0.14-0.35]). The intervention group had a lower prevalence of underweight (23.9% vs 32.6%; risk difference, -8.75 [95% CI, -13.70 to -3.80] percentage points), stunting (20.1% vs 27.2%; risk difference, -7.17 [95% CI, -11.85 to -2.49] percentage points), wasting (13.9% vs 19.4%; risk difference, -5.52 [95% CI, -9.63 to -1.41] percentage points), and anemia (34.0% vs 72.5%; risk difference, -38.49 [95% CI, -44.36 to -32.61] percentage points) and higher cognitive scores (mean difference, 1.73 [95% CI, 0.32-3.14]), language scores (mean difference, 2.74 [95% CI, 1.51-3.98]), and motor composite scores (mean difference, 2.32 [95% CI, 1.25-3.38]). Nine children in the usual care group and 5 in the intervention group died. Conclusions and Relevance: Among term SGA infants, an integrated intervention improved weight and weight-for-age z scores at 12 months. Trial Registration: Clinical Trials Registry-India Identifier: CTRI/2021/11/037881.
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Chowdhury et al. (2026) conducted an RCT in Small-for-gestational-age (SGA) (n=1,300). Integrated intervention package vs. Usual care was evaluated on Weight at 12 months (MD 0.22, 95% CI 0.11-0.32). An integrated intervention package improved mean weight by 0.22 kg (95% CI, 0.11-0.32) and weight-for-age z scores at 12 months compared to usual care among term small-for-gestational-age infants.
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