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

NCT03212547 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 140

Last updated 2019-01-29

No results posted yet for this study

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.

Conditions

  • Social Withdrawal of Childhood or Adolescence
  • Preterm Infant

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".

Sponsors & Collaborators

  • Clinica Alemana de Santiago

    lead OTHER

Principal Investigators

  • Jorge Bustamante Loyola, Phd student · Clínica Alemana de Santiago

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
1 Day
Max Age
3 Days
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-09-19
Primary Completion
2020-05-19
Completion
2020-07-19

Countries

  • Chile

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03212547 on ClinicalTrials.gov