Very Low Birth Weight Preterm Infant Bundled Care in the NICU
|ClinicalTrials.gov Identifier: NCT03370757|
Recruitment Status : Completed
First Posted : December 12, 2017
Last Update Posted : October 1, 2020
|Condition or disease||Intervention/treatment||Phase|
|Preterm Infants||Other: 3-hour bundled care Other: 6-hour bundled care||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||49 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Infants will be randomly assigned and stratified by birth weight (≤ 800 grams, >800 grams to 1150 grams, > 1150 grams) to either 3- or 6- hour bundled diaper care.|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Very Low Birthweight (VLBW) Preterm Infant Skin Health With Bundled Care in the Neonatal Intensive Care Unit (NICU): A Randomized Controlled Trial|
|Actual Study Start Date :||February 2, 2018|
|Actual Primary Completion Date :||August 23, 2019|
|Actual Study Completion Date :||August 23, 2019|
Active Comparator: 3-hour bundled care
Infants in this group will have their diaper changed every 3 hours during 3-hour bundled care.
Other: 3-hour bundled care
Infants in the 3-hour bundled care group will receive diaper changes every 3 hours with observational coding, microbiome samples, skin pH measurements and trans epidermal water loss measurements taken 3 times per week.
Active Comparator: 6-hour bundled care
Infants in this group will have their diaper changed every 6 hours.
Other: 6-hour bundled care
Infants in the 6-hour bundled care group will receive diaper changes every 6 hours with observational coding, microbiome samples, skin pH measurements and trans epidermal water loss measurements taken 4 times per week.
- Change in infants physiological stability as measured by infant vital signs [ Time Frame: 3 hours, 6 hours ]Vital signs will be analyzed to determine physiological stability.
- Change in infant skin health as measured by transepidermal water loss (TEWL). [ Time Frame: 3 hours, 6 hours ]TEWL will be calculated by taking the difference between two vapor pressure gradient measures (humidity and temperature) using a DermaLab TEWL skin probe.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03370757
|United States, North Carolina|
|Durham, North Carolina, United States, 27710|
|Principal Investigator:||Debra Brandon, PhD||Duke University|