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Completed

NCT Number: NCT03013023

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

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.

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Key information

Conditions

Early Interventions Behavior Parent-Child Relations Preterm Infants

Age range

28 week–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

BS

Behavioral

NNS, FT, positional support, and oral sucrose feeding

Routine Care

Behavioral

Routine NICU care

PITP

Behavioral

Parents will learn to regulate infant responses while implementing caregiving activities.

BS+PITP

Behavioral

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 outcomes

  1. Parent stress

    Time frame: 7days to 12 months

    Accessed by Parenting Stress Index-Short form (PSI-SF)

  2. Parent depression

    Time frame: 7days to 12 months

    Accessed by the Edinburgh Postnatal Depression Scale (EPDS)

  3. Parent sleep

    Time frame: 7days to 12 months

    Accessed by Pittsburgh Sleep Quality Index

  4. Parent social support

    Time frame: 7days to 12 months

    Accessed by the Social Support Rating Scale (SSRS)

Secondary outcomes

  1. Parent-infant interaction

    Time frame: 1 month to 6 months

    Assessed by NCASTfeeding scale

  2. Preterm infant's sleep

    Time frame: up to 3 months

    Assessed by Actigraphy

  3. Preterm infant's stress

    Time frame: up to 3 months

    Assessed by Salivary cortisol

Sponsors and collaborators

Lead sponsor

National Defense Medical Center, Taiwan

Other

Collaborators

  • Ministry of Science and Technology, Taiwan

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Jan 6, 2017
Registry last updated
Nov 3, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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