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COMPLETED
NCT03212547
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The Effect of a Neonatologist's Standardized Guidance Intervention on Preterm Infants With Relational Withdrawal.

Sponsor: Clinica Alemana de Santiago

View on ClinicalTrials.gov

Summary

The objective of this project is to determine the effect of the verbal intervention on the decrease in sustained social withdrawal in late and moderately late preterm infants. The intervention will be performed by pediatricians trained in the Alarm Distress Baby Scale (ADBB). This scale has been applied to term and preterm newborns in multiple international studies, but it has not yet been applied in Chile, nor with moderately late and late preterm infants. Infants are social beings who are born with innate reciprocal communication skills that can be observed during the two first months after delivery in babies with normal development. These skills include abilities to make and maintain eye contact, to vocalize and to use facial expressions, body and head movements to start interactions. Micro-analytical studies have demonstrated the frequent appearance of short episodes of social withdrawal affecting the infant during mother-baby interactions, whose function is to regulate the interaction flow. This behavior can be perceived when the infant needs to calm down or when is tired, and as a reaction to transitory interaction disturbances. In contrast with these short episodes of social withdrawal, the occurrence of sustained social withdrawal in infants is significantly less and is frequently associated with pathological conditions, such as autism spectrum disorder, child depression, and severe or chronic pain. Additionally, sustained social withdrawal is a symptom of anxiety and post-traumatic stress disorders. Different studies have revealed a prevalence of 11-22% in pre-term infant populations. In addition, the increase in sustained social withdrawal has been related to deviations of the interaction skills, attachment, as well as to relational and behavioral disorders. The increase and chronification of sustained social withdrawal, used as a defensive conduct, imply a risk to the adequate development of an infant's potential and raise the probability of alterations in the development of his psychopathology.

Official title: The Effect of a Neonatologist's Standardized Guidance Intervention on Late and Moderately Late Preterm Infants With Sustained Social Withdrawal: a Randomized Controlled Trial in Chile.

Key Details

Gender

All

Age Range

1 Day - 3 Days

Study Type

INTERVENTIONAL

Enrollment

110

Start Date

2017-09-19

Completion Date

2021-03-01

Last Updated

2026-09-15

Healthy Volunteers

No

Interventions

BEHAVIORAL

Verbal Intervention

Promotion of verbal interventions: 1. Detecting whether the infant has social withdrawal. 2. The physician will verbally intervene. 3. Positive response (+) from the infant, the evaluator will point out this to the parents. 4. Negative response (-) from the infant, the evaluator will include the parents in the interaction. 5. If he infant establishes positive contact (+) with the parents, he/she will point out this response to them. 6. If the infant does not establish positive contact (-)with the parents, repeat step 2. 7. If the infant offers a positive response (+) to the second attempt of verbal intervention, the evaluator will point out this response to the parents. 8. At the end of each medical check-up, give and explain the "ADBB Intervention Sheet".

Locations (2)

Clinica Alemana de Santiago

Santiago, Santiago Metropolitan, Chile

Hospital San Jose

Santiago, Santiago Metropolitan, Chile