Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Ministry of Science and Technology, Taiwan | OTHER_GOV |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
The proposed study has five specific aims:
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Routine care | Placebo Comparator | Control group |
|
| Behavioral-support interventions (BS) | Active Comparator | NNS, FT, positional support, and oral sucrose feeding will be provided while infants are undergoing painful procedures |
|
| Parent-infant transaction program (PITP) | Active Comparator | 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. |
|
| BS+PITP | Active Comparator | Behavioral-support interventions + Parent-infant transaction program |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BS | Behavioral | NNS, FT, positional support, and oral sucrose feeding |
|
| Measure | Description | Time Frame |
|---|---|---|
| Parent stress | Accessed by Parenting Stress Index-Short form (PSI-SF) | 7days to 12 months |
| Parent depression | Accessed by the Edinburgh Postnatal Depression Scale (EPDS) | 7days to 12 months |
| Parent sleep | Accessed by Pittsburgh Sleep Quality Index | 7days to 12 months |
| Parent social support | Accessed by the Social Support Rating Scale (SSRS) | 7days to 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Parent-infant interaction | Assessed by NCASTfeeding scale | 1 month to 6 months |
| Preterm infant's sleep | Assessed by Actigraphy | up to 3 months |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Jen-Jiuan Liaw, Professor | Professor, School of Nursing, National Defense Medical Center, Taipei, Taiwan, ROC. | Study Chair |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D001519 | Behavior |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Routine care | Behavioral | Routine NICU care |
|
| PITP | Behavioral | Parents will learn to regulate infant responses while implementing caregiving activities. |
|
| BS+PITP | Behavioral | 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. |
|
| Preterm infant's stress | Assessed by Salivary cortisol | up to 3 months |