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

BackgroundSustained social withdrawal is a key indicator of child emotional distress and a risk factor for psychological development. Preterm infants have a higher probability of developing sustained social withdrawal than infants born full-term during their first year.ObjectiveTo compare the effect of a behavioral guidance intervention to that of routine pediatric care on sustained social withdrawal behavior in preterm infants.DesignMulticenter randomized clinical trial.ParticipantsNinety nine moderate and late preterm newborns and their parents were recruited and randomized into two groups, i.e., Intervention (n = 49) and Control (n = 50). Both groups attended medical check-ups at 2, 6 and 12 months and were assessed with the Alarm Distress Baby Scale. The intervention group received a standardized behavioral intervention if the neonatologist detected sustained social withdrawal. Also, parents filled out the Edinburgh Postnatal Depression Scale, the modified-Perinatal Posttraumatic Stress Disorder Questionnaire, and the Impact of Event Scale-revised.ResultsAt baseline, the prevalence of withdrawal was 4.0% (95% CI: 0.03–14.2) for the control group and 22.4% (95% CI: 13.0–35.9) for the intervention group [OR = 0.22, p = 0.028 (95% CI =0.06–0.84)]. At 6 months, the prevalence was 10.0% (95% CI: 3.9–21.8) for the control group and 6.1% (95% CI: 2.1–16.5) for the intervention group [OR = 2.09, p = 0.318 (95% CI = 0.49–8.88)]. At 12 months, the prevalence was 22.0% (95% CI: 12.8–35.2) for the control group and 4.1% (95% CI: 1.1–13.7) for the intervention group [OR = 6.63, p = 0.018 (95% CI = 1.39–31.71)]. Logistic generalized estimating equation models were performed. The pooled crude OR (considering diagnosis at 6 and 12 months) was 3.54 [p = 0.022 (95% CI = 1.20–10.44); Cohen's d= 0.70]. In the case of pooled adjusted OR, the model considered diagnosis (0 = Withdrawal, 1 = Normal) as the dependent variable, time of evaluation (1= 6 months, 2 = 12 months) and group (0 = Control, 1 = Experimental) as factors. In this case, the pooled adjusted OR was 3.57 [p = 0.022 (95% CI = 1.20–10.65); Cohen's d = 0.70].ConclusionAssessment and intervention of sustained social withdrawal in preterm infants via standardized instruments benefits families by reducing its prevalence, and possible associated negative outcomes.Clinical Trial RegistrationClinicalTrials.gov; https://clinicaltrials.gov/ct2/show/NCT03212547, identifier: NCT03212547.

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. CLINICALTRIAL ClinicalTrials.gov NCT03212547; https://clinicaltrials.gov/ct2/show/NCT03212547. INTERNATIONAL REGISTERED REPORT DERR1-10.2196/17943