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

National Defense Medical Center, Taiwan

Status: Completed

Conditions: Preterm Infants; Early Interventions; Parent-Child Relations

Treatments: Behavioral: BS+PITP; Behavioral: Routine care; Behavioral: BS; Behavioral: PITP

Study type: Interventional

Funder types: Other

Identifiers

NCT03013023

1-103-05-165

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 60 patients

Sex: All

Ages: 28 weeks to 50 years old

Volunteers: Accepts 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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 4 patient groups, including a placebo group

Routine care

Placebo Comparator group

Description:

Control group

Treatment:

Behavioral: Routine care

Behavioral-support interventions (BS)

Active Comparator group

Description:

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

Treatment:

Behavioral: BS

Parent-infant transaction program (PITP)

Active Comparator group

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.

Treatment:

Behavioral: PITP

BS+PITP

Active Comparator group

Description:

Behavioral-support interventions + Parent-infant transaction program

Treatment:

Behavioral: BS+PITP