Very Low Birth Weight Preterm Infant Bundled Care in the NICU

NCT03370757 | Completed Results

• 1 other identifier: Pro00086595
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Preterm Infants

Outcome Measures

Primary Outcomes (1)

• Mean Heart Rate by Group

  Heart rate instability was defined as having a mean heart rate value during a bundled care event that was ≥1 standard deviation above or below the mean heart rate value during the 90 minutes before the event started. In addition, clinically meaningful parameters were added to indicate exceptions to this definition. For HR, mean values ≥ one standard deviation below the mean was categorized as physiologically unstable only if the mean value was \< 100. Based on these criteria, each observation was categorized as physiologically unstable or not.

  During hospitalization, approximately four weeks

Secondary Outcomes (2)

• Estimates of Infant Buttock Transepidermal Water Loss (TEWL) by Group

  During hospitalization, approximately four weeks

• Microbiota Diversity of the Skin at Both the Buttocks and Chest Sites and Stool by Group

  During hospitalization, approximately four weeks

Study Arms (2)

3-hour bundled care

ACTIVE COMPARATOR

Infants in this group will have their diaper changed every 3 hours during 3-hour bundled care.

Other: 3-hour bundled care

6-hour bundled care

ACTIVE COMPARATOR

Infants in this group will have their diaper changed every 6 hours.

Other: 6-hour bundled care

Interventions

3-hour bundled care OTHER

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.

3-hour bundled care

6-hour bundled care OTHER

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.

6-hour bundled care

Eligibility Criteria

• Age: Up to 32 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Duke University: lead
• Kimberly-Clark Corporation: collaborator

Study Sites (1)

Duke University

Durham, North Carolina, 27710, United States

Location

Related Publications (1)

• Brandon DH, Hatch D, Barnes A, Vance AJ, Harney J, Voigtman B, Younge N. Impact of diaper change frequency on preterm infants' vital sign stability and skin health: A RCT. Early Hum Dev. 2022 Jan;164:105510. doi: 10.1016/j.earlhumdev.2021.105510. Epub 2021 Nov 20.

  PMID: 34896732 DERIVED

Results Point of Contact

• Title: Dr. Debra Brandon
• Organization: Duke University School of Nursing

debra.brandon@duke.edu

919-681-3813

Study Officials

• Debra Brandon, PhD

  Duke University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: December 1, 2017
• First Posted: December 12, 2017
• Study Start: February 2, 2018
• Primary Completion: August 23, 2019
• Study Completion: August 23, 2019
• Last Updated: April 19, 2024
• Results First Posted: March 15, 2022

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)