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Interactive Guidance Intervention to Address Sustained Social Withdrawal in Preterm Infants in Chile: Protocol for a
Jorge Bustamante Loyola1,2,3,4, Marcela Perez Retamal1, Monica Isabel Morgues Nudman4
1Neonatology Unit, Clinica Alemana de Santiago, Santiago, Chile.
Insights
This study investigates an interactive guidance intervention to reduce social withdrawal in preterm infants. Early intervention shows potential for widespread healthcare implementation due to its low cost and integration into routine care.
Area of Science:
- Neonatal development and developmental psychology.
- Clinical trials and intervention studies.
Background:
- Preterm infants face significant perinatal stress, increasing risks for altered socioemotional development.
- Sustained social withdrawal in infants is an early indicator of emotional distress and is linked to later psychological development.
- Preterm infants have a higher probability of developing sustained social withdrawal compared to full-term infants.
Purpose of the Study:
- To compare an interactive guidance intervention with routine care for sustained social withdrawal in moderate to late preterm infants.
- To explore the relationship between social withdrawal and factors like NICU hospitalization, parental depression, and PTSD symptoms.
Main Methods:
- A multicenter randomized controlled trial involving 110 moderate and late preterm infants and their parents.
- Data collection included skin-to-skin contact, breastfeeding, parental visits, neonatal pain scores, and invasive procedures during NICU hospitalization.
- Infants were assessed for sustained social withdrawal using the Alarm Distress Baby Scale at 2, 6, and 12 months corrected age; parents completed depression and PTSD questionnaires.
Main Results:
- Enrollment of 110 infants was completed by May 2020.
- Study results are anticipated for publication by mid-2021.
- The trial is registered on ClinicalTrials.gov (NCT03212547).
Conclusions:
- This is the first RCT of an interactive guidance intervention for moderate/late preterm infants during pediatric follow-up.
- The intervention, delivered by neonatologists trained in the Alarm Distress Baby Scale, targets sustained social withdrawal.
- If successful, this low-cost intervention has significant potential for public and private healthcare implementation.
Background:
Preterm newborns can be exposed early to significant perinatal stress, and this stress can increase the risk of altered socioemotional development. Sustained social withdrawal in infants is an early indicator of emotional distress which is expressed by low reactivity to the environment, and if persistent, is frequently associated with altered psychological development. Infants born prematurely have a higher probability of developing sustained social withdrawal (adjusted odds ratio 1.84, 95% CI 1.04-3.26) than infants born full term, and there is a correlation between weight at birth and sustained social withdrawal at 12 months of age.
Objective:
The aims of this study are to compare the effect of the interactive guidance intervention to that of routine pediatric care on sustained social withdrawal in infants born moderately or late preterm and to explore the relationship between sustained social withdrawal in these infants and factors such as neonatal intensive care unit hospitalization variables, parental depression, and posttraumatic stress symptoms.
Methods:
This study is designed as a multicenter randomized controlled trial. Moderate and late preterm newborns and their parents were recruited and randomized (1:1 allocation ratio) to control and experimental groups. During neonatal intensive care unit hospitalization, daily duration of skin-to-skin contact, breastfeeding, and parental visits were recorded. Also, a daily score for neonatal pain and painful invasive procedures were recorded. After discharge from neonatal intensive care, for the duration of the study, both groups will attend follow-up consultations with neonatologists at 2, 6, and 12 months of age (corrected for gestational age) and will receive routine pediatric care. Every consultation will be recorded and assessed with the Alarm Distress Baby Scale to detect sustained social withdrawal (indicated by a score of 5 or higher). The neonatologists will perform an interactive guidance intervention if an infant in the intervention group exhibits sustained social withdrawal. In each follow-up consultation, parents will fill out the Edinburgh Postnatal Depression Scale, the modified Perinatal Posttraumatic Stress Disorder Questionnaire, and the Impact of Event Scale-revised.
Results:
Recruitment for this trial started in September 2017. As of May 2020, we have completed enrollment (N=110 infants born moderately or late preterm). We aim to publish the results by mid-2021.
Conclusions:
This is the first randomized controlled trial with a sample of infants born moderately or late preterm infants who will attend pediatric follow-up consultations during their first year (corrected for gestational age at birth) with neonatologists trained in the Alarm Distress Baby Scale and who will receive this interactive guidance intervention. If successful, this early intervention will show significant potential to be implemented in both public and private health care, given its low cost of training staff and that the intervention takes place during routine pediatric follow-up.
Trial Registration:
ClinicalTrials.gov NCT03212547; https://clinicaltrials.gov/ct2/show/NCT03212547.
International Registered Report Identifier (Irrid):
DERR1-10.2196/17943.
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