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Completed
NCT03212547
The Effect of a Neonatologist's Standardized Guidance Intervention on Preterm Infants With Relational Withdrawal.
Conditions: Social Withdrawal of Childhood or Adolescence, Preterm Infant
Sex: All
Ages: 1 Day – 3 Days
Healthy volunteers: No
Phase: NA
Enrollment: 110
Sponsor: Clinica Alemana de Santiago
Location: Clinica Alemana de Santiago Santiago Santiago Metropolitan
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.
Eligibility Criteria
Inclusion Criteria:
* 32 to 36+6 week preterm chilean newborn. Gestational age assigned by neonatologist at birth.
* Spanish speaking parents.
* Parents with stable cohabiting and both of them responsible for the care of the infant
* Double or single pregnancy (monochorionic or bichorionic).
* Born and hospitalized within the first 48 hours of life or with a stay of at least 48 hours at Clínica Alemana de Santiago or at Hospital San José.
* Signed informed consent.
Exclusion Criteria:
* Mother with antecedents or confirmed exposure to cocaine, marihuana or cocaine crack during pregnancy
* Neurological disease that impairs the infant's development confirmed at birth.
* Major congenital malformations or genetic diseases suspected or confirmed antenatally or at birth.
* Perinatal asphyxia: \
Source: ClinicalTrials.gov (NCT03212547). StuddyBuddy aggregates publicly available trial information.