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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03013023
Other study ID # 1-103-05-165
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


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
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