JMIR Publications

ABSTRACT

Background:

Preterm newborns can be exposed early to significant perinatal stress that can increase the risk of alterations of the socioemotional development. The sustained social withdrawal (SSW) in infants is understood as an early indicator of emotional distress expressed by low reactivity to the environment and, when durable, is frequently associated with alterations of psychological development. Preterm infants present a higher probability of developing SSW [adjusted Odds Ratio = 1.84 (1.04–3.26)] than infants born full term, and there is a correlation between birth weight and SSW at 12 months of age.

Objective:

The aims of this study are (1) to compare the effect of a interactional guidance intervention (IGI), performed by neonatologists trained in the Alarm Distress Baby Scale (ADBB), on the SSW scores of a moderate and late preterm (MLP) population versus routine pediatric care, (2) explore relations between NICU hospitalization variables with SSW scores and (3) explore relations between parents depression and posttraumatic stress symptoms with SSW scores after medical discharge.

Methods:

A multicenter randomized controlled trial (RCT) will be performed. 110 MLP newborns and their parents will be recruited and randomized to control (n=55) and experimental group (n=55) during NICU hospitalization. Daily minutes of skin to skin contact, breastfeeding, and parents visiting time will be recorded. Also, a score of daily neonatal pain and the number of daily painful-invasive procedures will be recorded. After NICUs discharge, both groups will attend to follow-up consultations with neonatologists at 2, 6 and 12 months of corrected age and will receive routine pediatric care. The neonatologists will perform an IGI if they detect SSW by assessing with the ADBB scale on the experimental group. In each follow-up consultation parents will fill out the Edinburgh Post-natal Depression Scale, the Modified Perinatal Posttraumatic Stress Disorder Questionnaire and the Revised Impact of Events Scale.

Results:

Recruitment for this trial started in September 2017. As of January 2020, we have enrolled 98 MLP infants. We aim to publish the results in a manuscript by April 2021.

Conclusions:

This is the first RCT with a sample of MLP infants that attend to pediatric follow-up consultations during their first year of corrected age with neonatologists trained in the ADBB scale and in the IGI. If successful, this early intervention will show significant potential to be implemented on both public and private health system, considering the low cost of training staff and that the intervention is made during the standardized pediatric follow-up consultations. Clinical Trial: ClinicalTrials.gov NCT03212547; https://clinicaltrials.gov/ct2/show/NCT03212547