Abstract
Background: Early intervention (EI) has been believed to improve the neurodevelopment of early preterm infants. However, its implementation in medical settings is time-consuming and resource-intensive, which limits its extensive use. In 2018, the Chinese Eugenics Association developed a home-based, post-discharge EI program. This study aims at evaluating the effect of this EI program on neurodevelopment and physical growth of early preterm infants through a prospective, partially blinded, randomized controlled trial, and a subsequent open phase. Methods: A total of 73 infants born at 28+0～31+6 weeks’ gestation with postmenstrual age of 36+0～39+6weeks were randomly allocated to the first early intervention, then standard care (EI-SC) group (37 infants), and the first standard care, then early intervention (SC-EI) group (36infants). Another 33 infants were retrospectively recruited as the reference group. The test of infant motor performance (TIMP) was the primary outcome, while development quotient (DQ) and anthropometric measures, including weight, length, and head circumference, were the secondary outcome. The assessment was carried out at the baseline (T0), termination of the randomized controlled trial (T1), and termination of the open phase (T2), respectively. Results: During the randomized controlled trial, the EI-SC group had significantly higher delta change (T1-T0) than the SC-EI group in TIMP and anthropometric measures (p<0.05), while no difference in DQ was noted between groups (p>0.05). In terms of the delta change from T2 to T0, there was no significant difference in all outcomes between the EI-SC group and SC-EI group (p>0.05). At the endpoint of T2, the EI-SC and SC-EI group had similar TIMP and anthropometric measures, but much higher than the reference group. Conclusions: These findings demonstrated that a home-based, post-discharge EI program in this study was a practical approach to promote motor development and physical growth in early preterm infants. Trial Registration: CHICTR, CTR1900028330, registered December 19, 2019, https:// http://www.chictr.org.cn/showproj.aspx?proj=45706
Effects of home-based early intervention on child outcomes: A randomized controlled trial of Parents as Teachers in Switzerland
