Elsevier

The Journal of Pediatrics

Volume 246, July 2022, Pages 80-88.e4
The Journal of Pediatrics

Original Article
Thirteen-Year Outcomes of a Randomized Clinical Trial of Early Preventive Care for Very Preterm Infants and Their Parents

https://doi.org/10.1016/j.jpeds.2022.03.013Get rights and content

Objective

To evaluate 13-year outcomes of a randomized controlled trial of preventive care (VIBeS Plus) for infants born very preterm and their parents and examine whether possible effects of intervention varied by family social risk.

Study design

Families were randomized to an intervention arm (n = 61) or a standard care arm (n = 59). The intervention was delivered at home by psychologists and physiotherapists over the infants’ first year, focusing on infant development and parental mental health. At 13 years corrected age, cognitive, motor, and behavioral outcomes, and parental mental health were assessed. Primary estimands were between-group mean differences, estimated using multiple imputed regression models.

Results

Follow-up included 81 surviving children (69%). There was little evidence of benefits of the intervention for IQ, attention, executive functioning, working memory, and academic skills regardless of level of social risk. Specifically, mean differences in adolescent cognitive outcomes ranged from −2.0 units (95% CI, −9.9 to 5.9) in favor of standard treatment to 5.1 units (95% CI, −2.3 to 12.5) favoring the intervention. A group-by-social risk interaction was observed only for adolescent motor outcomes, with mean differences favoring the intervention for those at higher social risk (balance, 4.9; 95% CI, 1.3-8.5; total motor, 3.2; 95% CI, 0.3-6.2), but not those at lower social risk (balance, −0.3; 95% CI, −2.4 to 1.9; total motor, 0.03; 95% CI, −1.9 to 2.0). Mean differences in adolescent behavior and parental mental health ranged from −6.6 (95% CI -13.8, 0.5) to −0.2 (95% CI, −1.9 to 1.4) and −1.8 (95% CI, −4.1 to 0.6) to −1.7 (95% CI, −4.3 to 1.0), respectively, indicating a pattern of fewer symptoms in the intervention group.

Conclusions

Benefits of the intervention persisted for adolescent behavior, with better motor outcomes observed in those from socially disadvantaged families. Replication with larger samples, multiple informant reports, and assessment of quality of life–related outcomes is warranted.

Trial registration

http://www.anzctr.org.au/: ACTRN12605000492651

Section snippets

Methods

This RCT of the VIBeS Plus program has been described previously (trial registration number ACTRN12605000492651).15,16 In this RCT, 120 consenting families were allocated at random to the intervention arm (n = 61) or standard care control arm (n = 59), stratified for cerebral white matter injury (normal-mild or moderate-severe) on neonatal magnetic resonance imaging22 and multiple births. Participants have been followed up at 2, 4, and 8 years, and the present study focuses on 13-year outcomes.

Results

At age 13 years, 69% of surviving children who participated in the VIBeS Plus trial were assessed (Figure 1). Although 102 participants (86%) were eligible and contactable at the end of the 8-year follow-up, recruitment was stopped prematurely because of coronavirus-19–related government restrictions. The percentage of missing values across all outcomes ranged from 31% to 35% owing to sample attrition and incomplete data across some outcomes, for such reasons as unreturned questionnaires or

Discussion

Our data show selective benefits of a home-based, parent-facilitated preventive care program (VIBeS Plus) for children born VP at age 13 years. Although we found some evidence of improved adolescent behavioral outcomes in the intervention group compared with their peers in the standard care group regardless of family level of social risk at term, we found little evidence of cognitive benefits associated with the intervention. There was moderate evidence of better motor outcomes in adolescents

Data Statement

Data sharing statement available at www.jpeds.com.

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  • Cited by (0)

    This research was supported by grants from the National Health and Medical Research Council (Project Grant 284512; Centre of Research Excellence in Newborn Medicine Grants 1060733 and 1153176; Senior Research Fellowship 1081288 and Investigator Grant 1176077, to P.A.; Career Development Fellowship 1108714, to A.S.), as well as the Cerebral Palsy Alliance Project, Murdoch Children's Research Institute, Myer Foundation, Allens Arthur Robinson Foundation, Thyne Reid Foundation, Victorian Government's Operational Infrastructure Support Program, and Monash University School of Psychological Sciences Research Support Fund. The funders did not participate in the study design; data collection; statistical analyses/interpretation; preparation, review, and approval of the final manuscript; or the decision to submit the manuscript for publication. The authors declare no conflicts of interest.

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