Status:

COMPLETED

Very Low Birth Weight Preterm Infant Bundled Care in the NICU

Lead Sponsor:

Duke University

Collaborating Sponsors:

Kimberly-Clark Corporation

Conditions:

Preterm Infants

Eligibility:

All Genders

Up to 32 years

Phase:

NA

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 Neona...

Detailed Description

Preterm infants' growth and developmental outcomes vary with illness severity and degree of neurological insult and unpredictable variations in outcomes exist even among healthy preterm infants. The v...

Eligibility Criteria

Inclusion

  • 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

  • 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.

Key Trial Info

Start Date :

February 2 2018

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

August 23 2019

Estimated Enrollment :

49 Patients enrolled

Trial Details

Trial ID

NCT03370757

Start Date

February 2 2018

End Date

August 23 2019

Last Update

April 19 2024

Active Locations (1)

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1

Duke University

Durham, North Carolina, United States, 27710