Early sleep intervention for improving infant sleep quality: a randomized controlled trial, preliminary result.

BACKGROUND: Healthy sleep issues should provide to family within first 6 months of infant's life. This study aimed to evaluate the effect of early sleep intervention on nighttime sleep quality.

METHODS: Eligible infants aged 4 months ± 2 weeks were randomized to receive early sleep intervention or usual care. Data on sleep variables were obtained via parental interview at baseline and 6 months of age. Using logistic regression to analyze the efficacy of early sleep intervention.

RESULTS: At baseline, 335 eligible infants were enrolled and randomized. In total, 306 participants were final analyzed: early sleep intervention group (n = 148) and the usual care group (n = 158). The early sleep intervention group had a significantly longer nighttime sleep duration and a shorter night waking duration than the usual care group (585.20 ± 80.38 min vs. 496.14 ± 87.78 min, p < .001 and 61.01 ± 36.38 min vs. 89.72 ± 45.54 min, p < .001). At 6 months of age, the early sleep intervention group had a longer night sleep duration (≥ 4 h/time) than the usual care group (adjusted odds ratio: 2.39, 95% confidence interval: 1.34-4.28).

CONCLUSIONS: Early sleep intervention should be recommended to infants at 4 months of age as a part of well childcare to improve infant sleep quality.

TRIAL REGISTRATION: Thai Clinical Trials Registry (thaiclinicaltrial.org). Retrospective registered TCTR20230117001 (17/01/2023).