Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03010891 |
| Other study ID # |
2-104-05-157 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
March 2016 |
| Est. completion date |
May 2018 |
Study information
| Verified date |
October 2020 |
| Source |
National Defense Medical Center, Taiwan |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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.
