Parent-Guided Developmental Intervention for Infants With Very Low Birth Weight: A Randomized Clinical Trial
Rita C Silveira1,2, Nadia C Valentini2, T Michael O'Shea3
1Neonatal Section, Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil.
Insights
Parent-guided early intervention significantly improved neurodevelopmental outcomes for preterm infants in a low-income country. This approach enhances cognitive function at 18 months corrected age.
Area of Science:
- Neonatal Medicine
- Developmental Pediatrics
- Global Health
Background:
- Early interventions are crucial for improving neurodevelopmental outcomes in preterm infants.
- Few studies have investigated early interventions for preterm infants in low- and middle-income countries (LMICs).
Purpose of the Study:
- To evaluate the effectiveness of a parent-guided early intervention program in enhancing neurodevelopmental outcomes for preterm infants within an LMIC setting.
Main Methods:
- A randomized clinical trial was conducted in Brazil involving preterm infants (gestational age <32 weeks or birth weight <1500g).
- Infants were randomized to either usual care or an enhanced developmental intervention including infant massage and stimulation, guided by parents.
- Neurodevelopmental outcomes were assessed using the Bayley Scales of Infant and Toddler Development-Third Edition at 18 months of corrected age.
Main Results:
- The enhanced developmental intervention group showed significantly higher cognitive scores at 18 months of corrected age compared to the usual care group (mean difference: 4.5; 95% CI, 0.1-8.9).
- The study included 100 infants, with a mean gestational age of 28.4 weeks.
Conclusions:
- Parent-guided early developmental interventions can effectively improve neurodevelopmental outcomes in very preterm infants born in LMICs.
- This intervention strategy offers a promising approach to support cognitive development in vulnerable infant populations in resource-limited settings.
Importance:
Early interventions improve neurodevelopmental outcomes after preterm birth, but few studies of early intervention have focused on preterm infants whose families reside in low- or middle-income countries (LMICs).
Objective:
To evaluate whether parent-guided early intervention improves the neurodevelopmental outcomes of preterm infants in an LMIC.
Design, Setting, And Participants:
This randomized clinical trial was performed at a high-risk obstetric referral hospital in Brazil, with outcome evaluations by examiners masked to randomization group. Eligibility criteria were (1) birth at the study hospital, (2) residence within 40 km of the birth hospital, and (3) gestational age of less than 32 weeks or birth weight of less than 1500 g. Of 138 enrolled infants, 19 died after randomization and 19 withdrew from the study; all other enrollees (50 per randomization group) were evaluated for the primary outcome. Data were collected from January 1, 2016, to May 31, 2022, and analyzed from June 10 to July 31, 2022.
Interventions:
On postnatal day 7, infants were randomized to usual care, consisting of support for lactation, kangaroo care, and routine developmental therapies, or to a parent-guided enhanced developmental intervention, consisting of usual care plus infant massage and enhanced visual stimulation, auditory stimulation, social interactions, and support for motor development, instructed by developmental therapists.
Main Outcomes And Measures:
The primary outcome was the Bayley Scales of Infant and Toddler Development-Third Edition score at 18 months of age adjusted for prematurity.
Results:
Among the 100 infants included in the analysis, mean (SD) gestational age was 28.4 (2.2) weeks, and 57 (57%) were male. The mean (SD) gestational age for the intervention group was 28.3 (2.3) weeks; for the usual care group, 28.5 (2.2) weeks. Female infants accounted for 21 infants (42%) of the intervention group and 22 (44%) of the usual care group; male infants, 29 (58%) and 28 (56%), respectively. The enhanced developmental intervention group had higher cognitive scores at 18 months of corrected age (mean [SD], 101.8 [11.9] vs 97.3 [13.5]; mean difference, 4.5 [95% CI, 0.1-8.9]).
Conclusions And Relevance:
In this randomized clinical trial of a parent-guided developmental intervention for early cognitive function of very preterm or very low birth weight infants implemented in an LMIC, the intervention improved very preterm infants' neurodevelopmental outcomes at 18 months of adjusted age. Parent-guided early intervention can improve neurodevelopmental outcome of very preterm infants born in LMICs.
Trial Registration:
ClinicalTrials.gov Identifier: NCT02835612.
