Clinical trial NCT03013023: Effects of Early Behavioral and Transaction Interventions on Preterm Infants' and Parents' Biopsychosocial Well-being
Official title: Early Behavioral and Transaction Interventions on Preterm Infants' and Parents' Biopsychosocial Well-being
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Early Interventions
Preterm Infants
Parent-Child Relations
Keywords: Behavioral and Transaction Interventions
Parents' Biopsychosocial Well-being
Preterm Infants
Sleep
Salivary cortisol
Lead sponsor: National Defense Medical Center, Taiwan
Sponsor class: OTHER
Collaborators: name: Ministry of Science and Technology, Taiwan
First posted: 2017-01-06
Enrollment: 60
Sex: ALL
Minimum age (years): 28
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Parent stress
timeFrame: 7days to 12 months
measure: Parent depression
timeFrame: 7days to 12 months
measure: Parent sleep
timeFrame: 7days to 12 months
measure: Parent social support
timeFrame: 7days to 12 months
Secondary outcomes:
measure: Parent-infant interaction
timeFrame: 1 month to 6 months
measure: Preterm infant's sleep
timeFrame: up to 3 months
measure: Preterm infant's stress
timeFrame: up to 3 months
Other outcomes:
Locations:
Study officials:
affiliation: Professor, School of Nursing, National Defense Medical Center, Taipei, Taiwan, ROC.
name: Jen-Jiuan Liaw, Professor
role: STUDY_CHAIR
References: