Effects of Early Behavioral and Transaction Interventions on Preterm Infants' and Parents' Biopsychosocial Well-being
NCT ID: NCT03013023
Last Updated: 2020-11-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
60 participants
INTERVENTIONAL
2015-04-30
2017-08-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
DOUBLE
Study Groups
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Routine care
Control group
Routine care
Routine NICU care
Behavioral-support interventions (BS)
NNS, FT, positional support, and oral sucrose feeding will be provided while infants are undergoing painful procedures
BS
NNS, FT, positional support, and oral sucrose feeding
Parent-infant transaction program (PITP)
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.
PITP
Parents will learn to regulate infant responses while implementing caregiving activities.
BS+PITP
Behavioral-support interventions + Parent-infant transaction program
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
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
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
28 Weeks
50 Years
ALL
Yes
Sponsors
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Ministry of Science and Technology, Taiwan
OTHER_GOV
National Defense Medical Center, Taiwan
OTHER
Responsible Party
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Hsiang-Yun Lan
Investigator, National Defense Medical Center, Taiwan
Principal Investigators
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Jen-Jiuan Liaw, Professor
Role: STUDY_CHAIR
Professor, School of Nursing, National Defense Medical Center, Taipei, Taiwan, ROC.
Other Identifiers
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1-103-05-165
Identifier Type: -
Identifier Source: org_study_id