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

NCT03212547 | Unknown DMC

• 1 other identifier: ADBB Chile
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

ADBB; social withdrawal behavior; preterm; posttraumatic stress; postpartum depression; early detection; interactional guidance; synchronization within parent infant interaction

Outcome Measures

Primary Outcomes (1)

• Sustained social withdrawal

  Quantitative categorical variable, ordinal. Category according sum of obtained scores (0-4: No withdrawal, 5-9: moderate withdrawal, 10 or more: Severe withdrawal).

  From date of the 2 months of corrected age medical checkup untill the date of the 12 months of corrected age medical checkup

Secondary Outcomes (7)

• Post-partum depression

  From date of the 2 months of corrected age medical checkup untill the date of the 12 months of corrected age medical checkup

• Post-traumatic stress symptoms

  From date of the 2 months of corrected age medical checkup untill the date of the 12 months of corrected age medical checkup

• Premature infant pain

  From date of admission to the NICU untill the date of medical discharge from the NICU or date of death from any cause, whichever came first, assessed up to 10 months

• Painful invasive procedures

  From date of admission to the NICU untill the date of medical discharge from the NICU or date of death from any cause, whichever came first, assessed up to 10 months

• Parental visiting time

  From date of admission to the NICU untill the date of medical discharge from the NICU or date of death from any cause, whichever came first, assessed up to 10 months

Study Arms (2)

Experimental group

EXPERIMENTAL

Verbal interventions made on infants (accompanied by their mothers) who presents sustained social withdrawal detected on the child consultations (at 2, 6 and 12 months of corrected gestational age), made by neonatologists certifieds in the assess of Alarm Distress Baby Scale. Theintervention is described in a guide for "Promotion of verbal interventions for interaction" , and will be supplemented with a written guideline for parents.

Behavioral: Verbal Intervention

Control group

NO INTERVENTION

Control group: infants will assist at child consultations (at 2, 6 and 12 months of corrected gestational age) whit non trained neonatologists. However, these group will receive a development stimulation guide adapted of the ministerial guides for the stimulation of development of the Ministry of Health of Chile.

Interventions

Verbal Intervention BEHAVIORAL

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".

Experimental group

Eligibility Criteria

• Age: 1 Day - 3 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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: \<3 Apgar score at 1 minute or \< 5 at 5 minutes and/or cord pH \<7.0

Sponsors & Collaborators

• Clinica Alemana de Santiago: lead

Study Sites (1)

Clinica Alemana de Santiago

Santiago, Santiago Metropolitan, 7650568, Chile

Location

Related Publications (2)

• Bustamante Loyola J, Perez Retamal M, Mendiburo-Seguel A, Guedeney AC, Salinas Gonzalez R, Munoz L, Cox Melane H, Gonzalez Mas JM, Simo Teufel S, Morgues Nudman M. The Impact of an Interactive Guidance Intervention on Sustained Social Withdrawal in Preterm Infants in Chile: Randomized Controlled Trial. Front Pediatr. 2022 Apr 1;10:803932. doi: 10.3389/fped.2022.803932. eCollection 2022.

  PMID: 35433551 DERIVED

• Bustamante Loyola J, Perez Retamal M, Morgues Nudman MI, Maturana A, Salinas Gonzalez R, Cox H, Gonzalez Mas JM, Munoz L, Lopez L, Mendiburo-Seguel A, Simo S, Palau Subiela P, Guedeney A. Interactive Guidance Intervention to Address Sustained Social Withdrawal in Preterm Infants in Chile: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2020 Jun 26;9(6):e17943. doi: 10.2196/17943.

  PMID: 32589156 DERIVED

MeSH Terms

Conditions

Premature Birth; Depression, Postpartum

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Puerperal Disorders; Depressive Disorder; Mood Disorders; Mental Disorders

Study Officials

• Jorge Bustamante Loyola, Phd student

  Clínica Alemana de Santiago

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participants: The families of the MLP infants will remain blind to the group they belong to. Families will receive feedback on their infant's ADBB scores only after the final assessment (12 months). Care providers: neonatologists who care for participants during the trial are aware if the participants enter to the experimental or control group. Investigator: the principal investigator (JB) is also an external evaluator. He is an ADBB- trained psychologist who doesn't participate in the follow-up of any of the participants. He is blind to the ADBB scores of the ADB- trained neonatologists. Outcome assessment: Regarding to the ADBB assessment, once the ADBB score is assigned, this data is collected by a study coordinator, also blind to the group category. Data collection assessors: They are not trained in the ADBB scale, and don't have contact with the participants or their families.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 7, 2017
• First Posted: July 11, 2017
• Study Start: September 19, 2017
• Primary Completion: May 19, 2020
• Study Completion: July 19, 2020
• Last Updated: January 29, 2019

Record last verified: 2019-01

Locations

CL (1)