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Trial record 34 of 761 for:    region | Chile

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

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ClinicalTrials.gov Identifier: NCT03212547
Recruitment Status : Enrolling by invitation
First Posted : July 11, 2017
Last Update Posted : January 29, 2019
Sponsor:
Information provided by (Responsible Party):
Clinica Alemana de Santiago

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.


Condition or disease Intervention/treatment Phase
Social Withdrawal of Childhood or Adolescence Preterm Infant Behavioral: Verbal Intervention Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking Description:

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.

Primary Purpose: Treatment
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.
Actual Study Start Date : September 19, 2017
Estimated Primary Completion Date : May 19, 2020
Estimated Study Completion Date : July 19, 2020

Arm Intervention/treatment
Experimental: Experimental group
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

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".

No Intervention: Control group
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.



Primary Outcome Measures :
  1. Sustained social withdrawal [ Time Frame: From date of the 2 months of corrected age medical checkup untill the date of the 12 months of corrected age medical checkup ]
    Quantitative categorical variable, ordinal. Category according sum of obtained scores (0-4: No withdrawal, 5-9: moderate withdrawal, 10 or more: Severe withdrawal).


Secondary Outcome Measures :
  1. Post-partum depression [ Time Frame: From date of the 2 months of corrected age medical checkup untill the date of the 12 months of corrected age medical checkup ]
    Quantitative categorical variable, nominal. Category obtained from scores lower or higher than 12 points in Edinburgh scale ("No risk" and "risk").

  2. Post-traumatic stress symptoms [ Time Frame: From date of the 2 months of corrected age medical checkup untill the date of the 12 months of corrected age medical checkup ]

    Quantitative categorical variable, nominal. Category obtained from scores lower or higher than 19 points in Modified Perinatal Post-traumatic Stress Disorder Questionnaire ("no risk" and "risk").

    Category obtained from scores lower or higher than 24 ("clinical concern") in Impact of Event Scale Revised (IES-R).


  3. Premature infant pain [ Time Frame: 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 ]
    Quantitative categorical variable, nominal. Categorys obtained from scores between 0 and 5 points (no pain), 6 and 11 points (pain) and 12 or more points (moderate to severe pain) in the "Premature Infant Pain Profile (PIPP)".

  4. Painful invasive procedures [ Time Frame: 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 ]
    Quantitative variable. Sum of the daily number of painful invasive procedures registered on the medical chart

  5. Parental visiting time [ Time Frame: 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 ]
    Quantitative variable. Sum of the daily minutes that the parents are visiting their preterm infants on the NICU

  6. Breastfeeding time [ Time Frame: 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 ]
    Quantitative variable. Sum of the daily minutes that the mothers are breastfeeding their preterm infants on the NICU

  7. Skin to skin contact time [ Time Frame: 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 ]
    Quantitative variable. Sum of the daily minutes that the parents are in skin to skin contact with their preterm infants on the NICU



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Ages Eligible for Study:   up to 3 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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: <3 Apgar score at 1 minute or < 5 at 5 minutes and/or cord pH <7.0

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03212547


Locations
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Chile
Clinica Alemana de Santiago
Santiago, Region Metropolitana, Chile, 7650568
Sponsors and Collaborators
Clinica Alemana de Santiago
Investigators
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Principal Investigator: Jorge Bustamante Loyola, Phd student Clínica Alemana de Santiago

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Responsible Party: Clinica Alemana de Santiago
ClinicalTrials.gov Identifier: NCT03212547     History of Changes
Other Study ID Numbers: ADBB Chile
First Posted: July 11, 2017    Key Record Dates
Last Update Posted: January 29, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Clinica Alemana de Santiago:
ADBB
social withdrawal behavior
preterm
posttraumatic stress
postpartum depression
early detection
interactional guidance
synchronization within parent infant interaction

Additional relevant MeSH terms:
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Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications