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Effects of Early Behavioral and Transaction Interventions on Preterm Infants' and Parents' Biopsychosocial Well-being

Primary Purpose

Early Interventions, Preterm Infants, Parent-Child Relations

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
BS
Routine care
PITP
BS+PITP
Sponsored by
National Defense Medical Center, Taiwan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Early Interventions focused on measuring Behavioral and Transaction Interventions, Parents' Biopsychosocial Well-being, Preterm Infants, Sleep, Salivary cortisol

Eligibility Criteria

28 Weeks - 50 Years (Child, Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. Gestational age (GA) > 28 weeks and < 37 weeks
  2. Postbirth age >2 days
  3. Stable condition (score<20 on the Neonatal Therapeutic Intervention Scoring System [NTISS] for disease severity).
  4. Parents are not diagnosed with mental illness or some other illness known to influence/confound the outcome variables
  5. Parents are fluent in Chinese
  6. Parents do not use drugs
  7. Parents agree to participate in this study

Exclusion Criteria:

  1. Congenital anomalies
  2. Neurologic impairment including convulsion, intraventricular hemorrhage > grade II or periventricular leukomalacia
  3. Documented congenital or nosocomial (infection acquired at hospital after birth) sepsis
  4. Surgery
  5. Severe medical conditions requiring treatments such as cortisol supplementation, sedatives, muscle relaxants, antiepileptic, or analgesic drugs

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Placebo Comparator

    Active Comparator

    Active Comparator

    Active Comparator

    Arm Label

    Routine care

    Behavioral-support interventions (BS)

    Parent-infant transaction program (PITP)

    BS+PITP

    Arm Description

    Control group

    NNS, FT, positional support, and oral sucrose feeding will be provided while infants are undergoing painful procedures

    The PITP will be a six-session, one-on-one teaching intervention beginning on day 22 after birth, with four sessions at bedside, and two home-visit sessions within the first month after discharge.

    Behavioral-support interventions + Parent-infant transaction program

    Outcomes

    Primary Outcome Measures

    Parent stress
    Accessed by Parenting Stress Index-Short form (PSI-SF)
    Parent depression
    Accessed by the Edinburgh Postnatal Depression Scale (EPDS)
    Parent sleep
    Accessed by Pittsburgh Sleep Quality Index
    Parent social support
    Accessed by the Social Support Rating Scale (SSRS)

    Secondary Outcome Measures

    Parent-infant interaction
    Assessed by NCASTfeeding scale
    Preterm infant's sleep
    Assessed by Actigraphy
    Preterm infant's stress
    Assessed by Salivary cortisol

    Full Information

    First Posted
    December 29, 2016
    Last Updated
    October 31, 2020
    Sponsor
    National Defense Medical Center, Taiwan
    Collaborators
    Ministry of Science and Technology, Taiwan
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03013023
    Brief Title
    Effects of Early Behavioral and Transaction Interventions on Preterm Infants' and Parents' Biopsychosocial Well-being
    Official Title
    Early Behavioral and Transaction Interventions on Preterm Infants' and Parents' Biopsychosocial Well-being
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2020
    Overall Recruitment Status
    Completed
    Study Start Date
    April 2015 (undefined)
    Primary Completion Date
    March 2017 (Actual)
    Study Completion Date
    August 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    National Defense Medical Center, Taiwan
    Collaborators
    Ministry of Science and Technology, Taiwan

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    This randomized controlled trial will use a longitudinal repeated-measures design to examine the effects of two interventions, behavioral support interventions and a parent-infant transactional program, on parents' stress, PPD and sleep quality, parent-infant interactions, and their preterm infants' stress (saliva cortisol levels), sleep patterns, emotional regulation, and neurobehavioral developmental outcomes from 7 days to 2 years corrected age.
    Detailed Description
    The proposed study has five specific aims: to develop behavioral-support interventions for preterm infants who receive painful, stressful procedures in the NICU, to develop a parent-infant transactional program (PITP) for parent-infant dyads with preterm infants in the NICU, to determine the short-term effects of the behavioral-support interventions and PITP on infant stress (salivary cortisol levels) and sleep patterns, to determine the short-term effects of the PITP on parental stress, depression, social support, and sleep quality during postpartum, and to determine the long-term effects of the behavioral-support interventions and PITP on parent-infant interactions and infants' long-term emotional regulation and neurobehavioral outcomes.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Early Interventions, Preterm Infants, Parent-Child Relations
    Keywords
    Behavioral and Transaction Interventions, Parents' Biopsychosocial Well-being, Preterm Infants, Sleep, Salivary cortisol

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    60 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Routine care
    Arm Type
    Placebo Comparator
    Arm Description
    Control group
    Arm Title
    Behavioral-support interventions (BS)
    Arm Type
    Active Comparator
    Arm Description
    NNS, FT, positional support, and oral sucrose feeding will be provided while infants are undergoing painful procedures
    Arm Title
    Parent-infant transaction program (PITP)
    Arm Type
    Active Comparator
    Arm Description
    The PITP will be a six-session, one-on-one teaching intervention beginning on day 22 after birth, with four sessions at bedside, and two home-visit sessions within the first month after discharge.
    Arm Title
    BS+PITP
    Arm Type
    Active Comparator
    Arm Description
    Behavioral-support interventions + Parent-infant transaction program
    Intervention Type
    Behavioral
    Intervention Name(s)
    BS
    Intervention Description
    NNS, FT, positional support, and oral sucrose feeding
    Intervention Type
    Behavioral
    Intervention Name(s)
    Routine care
    Intervention Description
    Routine NICU care
    Intervention Type
    Behavioral
    Intervention Name(s)
    PITP
    Intervention Description
    Parents will learn to regulate infant responses while implementing caregiving activities.
    Intervention Type
    Behavioral
    Intervention Name(s)
    BS+PITP
    Intervention Description
    Parents will learn to regulate infant responses while implementing caregiving activities. Supportive interventions, i.e., NNS, FT, positional support, and oral sucrose feeding, will be provided while infants are undergoing painful procedures.
    Primary Outcome Measure Information:
    Title
    Parent stress
    Description
    Accessed by Parenting Stress Index-Short form (PSI-SF)
    Time Frame
    7days to 12 months
    Title
    Parent depression
    Description
    Accessed by the Edinburgh Postnatal Depression Scale (EPDS)
    Time Frame
    7days to 12 months
    Title
    Parent sleep
    Description
    Accessed by Pittsburgh Sleep Quality Index
    Time Frame
    7days to 12 months
    Title
    Parent social support
    Description
    Accessed by the Social Support Rating Scale (SSRS)
    Time Frame
    7days to 12 months
    Secondary Outcome Measure Information:
    Title
    Parent-infant interaction
    Description
    Assessed by NCASTfeeding scale
    Time Frame
    1 month to 6 months
    Title
    Preterm infant's sleep
    Description
    Assessed by Actigraphy
    Time Frame
    up to 3 months
    Title
    Preterm infant's stress
    Description
    Assessed by Salivary cortisol
    Time Frame
    up to 3 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    28 Weeks
    Maximum Age & Unit of Time
    50 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Gestational age (GA) > 28 weeks and < 37 weeks Postbirth age >2 days Stable condition (score<20 on the Neonatal Therapeutic Intervention Scoring System [NTISS] for disease severity). Parents are not diagnosed with mental illness or some other illness known to influence/confound the outcome variables Parents are fluent in Chinese Parents do not use drugs Parents agree to participate in this study Exclusion Criteria: Congenital anomalies Neurologic impairment including convulsion, intraventricular hemorrhage > grade II or periventricular leukomalacia Documented congenital or nosocomial (infection acquired at hospital after birth) sepsis Surgery Severe medical conditions requiring treatments such as cortisol supplementation, sedatives, muscle relaxants, antiepileptic, or analgesic drugs
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Jen-Jiuan Liaw, Professor
    Organizational Affiliation
    Professor, School of Nursing, National Defense Medical Center, Taipei, Taiwan, ROC.
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Effects of Early Behavioral and Transaction Interventions on Preterm Infants' and Parents' Biopsychosocial Well-being

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