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Effects of Bundled Supportive Interventions on Preterm Infants' Stress-Related Outcomes During Invasive Procedures

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ClinicalTrials.gov Identifier: NCT03010891
Recruitment Status : Unknown
Verified January 2017 by Hsiang-Yun Lan, National Defense Medical Center, Taiwan.
Recruitment status was:  Enrolling by invitation
First Posted : January 5, 2017
Last Update Posted : January 6, 2017
Sponsor:
Collaborator:
Ministry of Science and Technology, Taiwan
Information provided by (Responsible Party):
Hsiang-Yun Lan, National Defense Medical Center, Taiwan

Brief Summary:
The proposed 2-year study has two specific aims: (1) to examine the effects of a "bundle" of supportive interventions on preterm infants' stress (salivary cortisol and dehydroepiandrosterone [DHEA] levels and physiological signals of infant distress), sleep, and physical activity in the NICU, and (2) to explore the relationships among preterm infants' salivary cortisol and DHEA levels, physiological signals of infant distress, sleep, and physical activity. This randomized controlled trial will adopt a longitudinal repeated-measures design to examine the effects of bundled supportive interventions on preterm infants' stress (salivary cortisol and DHEA levels [using ELISA kit] and physiological signals of infant distress [using bedside electrocardiographic monitors]), sleep and physical activity (using ankle actigraphy) during their NICU hospitalization. Preterm infants (N=120) meeting the study criteria will be randomly assigned to one of two conditions: (1) control condition: usual NICU care + positioning + gentle touch +routine kangaroo mother care (KMC) < 20 minutes; (2) experimental condition: the bundle of supportive interventions (usual NICU care +positioning + gentle touch + modulating infant states + facilitated tucking + non-nutritive sucking + oral sucrose+ routine KMC > 45 minutes. Outcome variables will include infants' biological responses to stress (salivary cortisol, salivary DHEA, and physiological signals of infant distress), sleep patterns, and physical activity.

Condition or disease Intervention/treatment Phase
Preterm Infants Stress Behavioral: The bundle of supportive interventions Behavioral: Usual NICU care Not Applicable

Detailed Description:

Background and purpose: Preterm infants need to receive intensive care in a neonatal intensive care unit (NICU) to survive, but this care exposes them to painful procedures and a stressful environment. Repeated, painful/stressful stimuli can disturb infants' sleep, change their physiological indicators, and affect their developing brain and organs, possibly resulting in negative, long-lasting developmental consequences. Therefore, NICU clinicians caring for these vulnerable infants have two important goals: to provide early interventions to minimize preterm infants' stress/pain and to improve their sleep and physical activity. The proposed 2-year study has two specific aims: (1) to examine the effects of a "bundle" of supportive interventions on preterm infants' stress (salivary cortisol and dehydroepiandrosterone [DHEA] levels and physiological signals of infant distress), sleep, and physical activity in the NICU, and (2) to explore the relationships among preterm infants' salivary cortisol and DHEA levels, physiological signals of infant distress, sleep, and physical activity.

Methods: This randomized controlled trial will adopt a longitudinal repeated-measures design to examine the effects of bundled supportive interventions on preterm infants' stress (salivary cortisol and DHEA levels [using ELISA kit] and physiological signals of infant distress [using bedside electrocardiographic monitors]), sleep and physical activity (using ankle actigraphy) during their NICU hospitalization. Preterm infants (N=120) meeting the study criteria will be randomly assigned to one of two conditions: (1) control condition: usual NICU care + positioning + gentle touch +routine kangaroo mother care (KMC) < 20 minutes; (2) experimental condition: the bundle of supportive interventions (usual NICU care +positioning + gentle touch + modulating infant states + facilitated tucking + non-nutritive sucking + oral sucrose+ routine KMC > 45 minutes. Outcome variables will include infants' biological responses to stress (salivary cortisol, salivary DHEA, and physiological signals of infant distress), sleep patterns, and physical activity.

Expected outcomes: The study will fill a gap in knowledge about the effects of bundled supportive interventions on preterm infants' stress reactivity, sleep, and physical activity during hospitalization. This unique combination of physiological measurements of preterm infants' stress parameters and longitudinal design will provide results for establishing evidence-based clinical guidelines to provide atraumatic care to this population during intrusive procedures. Investigators also expect that bundling supportive interventions will minimize preterm infants' pain/stress as well as improve their sleep and physical activity. In the long term, the study results may help reduce the morbidity and complications due to preterm birth, save medical costs in neonatal care, and promote these infants' health and future developmental outcomes.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: Effects of Bundled Supportive Interventions on Preterm Infants' Stress-Related Outcomes
Study Start Date : March 2016
Estimated Primary Completion Date : August 2017
Estimated Study Completion Date : March 2018

Arm Intervention/treatment
Active Comparator: control condition
Preterm infants in the control condition will receive only usual NICU care, plus positioning and gentle touch during intrusive procedures.
Behavioral: Usual NICU care
usual NICU care + positioning + gentle touch +routine KMC < 20 minutes

Experimental: experimental condition
The bundle of supportive interventions will be designed to alleviate preterm infants' stress/pain from birth to discharge from the hospital NICU.
Behavioral: The bundle of supportive interventions
usual NICU care +positioning + gentle touch + modulating infant states + facilitated tucking + NNS+ oral sucrose+ routine KMC > 45 minutes




Primary Outcome Measures :
  1. Preterm infant salivary cortisol [ Time Frame: up to 3 months ]
    Accessed by salivary cortisol ELISA kit


Secondary Outcome Measures :
  1. Preterm infant sleep [ Time Frame: up to 3 months ]
    Accessed by Actigraphy

  2. Preterm infant physiological signals of infant distress [ Time Frame: up to 3 months ]
    Accessed by bedside electrocardiographic monitor

  3. All preterm infants' physical activity are accessed by using Actigraphy [ Time Frame: up to 3 months ]
    Accessed by Actigraphy

  4. Preterm infant salivary DHEA levels [ Time Frame: up to 3 months ]
    Accessed by salivary DHEA ELISA kit



Information from the National Library of Medicine

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Ages Eligible for Study:   28 Weeks to 37 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • (1) gestational age (GA) > 28 weeks and < 37 weeks
  • (2) birth weight < 2100g
  • (3) stable condition (score < 22 on the Neonatal Therapeutic Intervention Scoring System [NTISS] for disease severity)
  • (4) parents can speak, read and write Chinese
  • (5) parents have no history of drug/alcohol abuse
  • (6) parents agree to participate

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03010891


Sponsors and Collaborators
National Defense Medical Center, Taiwan
Ministry of Science and Technology, Taiwan
Investigators
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Study Chair: Jen-Jiuan Liaw, Professor Professor, School of Nursing, 1National Defense Medical Center, Taipei, Taiwan, ROC.

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Responsible Party: Hsiang-Yun Lan, Investigator, National Defense Medical Center, Taiwan, National Defense Medical Center, Taiwan
ClinicalTrials.gov Identifier: NCT03010891     History of Changes
Other Study ID Numbers: 2-104-05-157
First Posted: January 5, 2017    Key Record Dates
Last Update Posted: January 6, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Hsiang-Yun Lan, National Defense Medical Center, Taiwan:
Preterm infant
Stress
Salivary DHEA
Salivary cortisol
Actigraphy
Additional relevant MeSH terms:
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Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications