N/A
N=48
Very Low Birth Weight Preterm Infant Bundled Care in the NICU
Preterm Infants
Bottom Line
View on ClinicalTrials.gov: NCT03370757 ↗Enrolled (actual)
48
Serious AEs
0.0%
Results posted
Mar 2022
Primary outcome: Primary: Mean Heart Rate by Group — 200; 185 beats per minute
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- 3-hour bundled care (Other); 6-hour bundled care (Other)
- Age
- Pediatric
- Sex
- All
- Sponsor
- Duke University
- Primary completion
- Aug 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Heart Rate by Group |
200; 185 | — |
| SECONDARY Estimates of Infant Buttock Transepidermal Water Loss (TEWL) by Group |
38.48; 35.73 | — |
| SECONDARY Microbiota Diversity of the Skin at Both the Buttocks and Chest Sites and Stool by Group |
4.14; 3.99; 4.14; 4.18; 4.16; 3.56 | — |
Summary
The purpose of this study is to explore the impact of bundling nursing care activities on the overall health of Very Low Birthweight (VLBW) preterm infants who receive bundled care in a Level IV Neonatal Intensive Care Unit (NICU). The study will evaluate differences in infant health when diaper changes occur at 3- versus 6-hours during 3-hour bundled care. Differences in infant skin health between 3- and 6-hour bundled care diapering at two sites (buttocks and chest) will also be evaluated.
Eligibility Criteria
Inclusion Criteria
- Must be participating in the Intensive Care Nursery standard 3-hour bundled care
- Must wear a breathable diaper
- Must be ≤ 32 weeks gestation at birth and weigh ≤ 1500g at birth.
- Infants are expected to remain hospitalized for at least 4 weeks
Exclusion Criteria
- Neonatal Abstinence Syndrome
- Humidified incubator
- Diaper rash
- Pre-existing or genetic skin conditions
- Use of barrier creams
- Severe illness requiring 1: 1 nursing care: e.g. minimal stimulation protocol, high frequency ventilation, vasopressor drug support, or body cooling.
Data sourced from ClinicalTrials.gov (NCT03370757). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.