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

National Defense Medical Center, Taiwan60 enrolled

Overview

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.

The proposed study has five specific aims: 1. to develop behavioral-support interventions for preterm infants who receive painful, stressful procedures in the NICU, 2. to develop a parent-infant transactional program (PITP) for parent-infant dyads with preterm infants in the NICU, 3. to determine the short-term effects of the behavioral-support interventions and PITP on infant stress (salivary cortisol levels) and sleep patterns, 4. to determine the short-term effects of the PITP on parental stress, depression, social support, and sleep quality during postpartum, and 5. 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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

DOUBLE

Enrollment

Conditions

Early Interventions Preterm Infants

Interventions

BSBEHAVIORAL

NNS, FT, positional support, and oral sucrose feeding

Routine careBEHAVIORAL

Routine NICU care

PITPBEHAVIORAL

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

BS+PITPBEHAVIORAL

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.

Eligibility

Sex: ALLMin age: 28 WeeksMax age: 50 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Parent stress

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

Time frame: 7days to 12 months

Parent depression

Accessed by the Edinburgh Postnatal Depression Scale (EPDS)

Time frame: 7days to 12 months

Parent sleep

Accessed by Pittsburgh Sleep Quality Index

Time frame: 7days to 12 months

Parent social support

Accessed by the Social Support Rating Scale (SSRS)

Time frame: 7days to 12 months

Secondary Outcomes

Parent-infant interaction

Assessed by NCASTfeeding scale

Time frame: 1 month to 6 months

Preterm infant's sleep

Assessed by Actigraphy

Time frame: up to 3 months

Preterm infant's stress

Assessed by Salivary cortisol

Time frame: up to 3 months