Early Interventions, Parent-Child Relations, Preterm Infants
Conditions
Keywords
Behavioral and Transaction Interventions, Parents' Biopsychosocial Well-being, Preterm Infants, Sleep, Salivary cortisol
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.
Interventions
BEHAVIORALBS
NNS, FT, positional support, and oral sucrose feeding
BEHAVIORALRoutine care
Routine NICU care
BEHAVIORALPITP
Parents will learn to regulate infant responses while implementing caregiving activities.
BEHAVIORALBS+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.
Sponsors
Ministry of Science and Technology, Taiwan
National Defense Medical Center, Taiwan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
28 Weeks to 50 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Parent social support | 7days to 12 months | Accessed by the Social Support Rating Scale (SSRS) |
| Parent stress | 7days to 12 months | Accessed by Parenting Stress Index-Short form (PSI-SF) |
| Parent depression | 7days to 12 months | Accessed by the Edinburgh Postnatal Depression Scale (EPDS) |
| Parent sleep | 7days to 12 months | Accessed by Pittsburgh Sleep Quality Index |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Preterm infant's sleep | up to 3 months | Assessed by Actigraphy |
| Preterm infant's stress | up to 3 months | Assessed by Salivary cortisol |
| Parent-infant interaction | 1 month to 6 months | Assessed by NCASTfeeding scale |
Outcome results
None listed