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

Parent-Child Relations Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03013023
• Other study ID #: 1-103-05-165
• Status: Completed
• Phase: N/A
• Start date: April 2015
• Est. completion date: August 2017

Study information

• Verified date: October 2020
• Source: National Defense Medical Center, Taiwan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: August 2017
• Est. primary completion date: March 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 28 Weeks to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Early Interventions
• Parent-Child Relations
• Premature Birth
• Preterm Infants

Intervention

Behavioral:
• BS
NNS, FT, positional support, and oral sucrose feeding
• Routine care
Routine NICU care
• PITP
Parents will learn to regulate infant responses while implementing caregiving activities.
• BS+PITP
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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
National Defense Medical Center, Taiwan	Ministry of Science and Technology, Taiwan

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Parent stress	Accessed by Parenting Stress Index-Short form (PSI-SF)	7days to 12 months
Primary	Parent depression	Accessed by the Edinburgh Postnatal Depression Scale (EPDS)	7days to 12 months
Primary	Parent sleep	Accessed by Pittsburgh Sleep Quality Index	7days to 12 months
Primary	Parent social support	Accessed by the Social Support Rating Scale (SSRS)	7days to 12 months
Secondary	Parent-infant interaction	Assessed by NCASTfeeding scale	1 month to 6 months
Secondary	Preterm infant's sleep	Assessed by Actigraphy	up to 3 months
Secondary	Preterm infant's stress	Assessed by Salivary cortisol	up to 3 months