Recruiting

Observational Study

Sponsor:

Augusta University

Code:

NCT06230172

Conditions

Hypothermia, Newborn

Body Temperature Changes

Newborn Thermal Injury

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Interventions

Weaning incubator (heat) at an lower postnatal weight

Study Details

Brief summary:

The purpose of this study is to determine the safety and feasibility of weaning from the incubator at a lower post-natal weight at 1600 grams. Our hypothesis is that early weaning from the incubator to a crib/bassinet is safe and may result in a decrease in length of hospital stay while maintaining appropriate growth velocity. Specific outcomes the investigators will evaluate are the length of hospital stay and growth velocity at early weaning.

Conditions

Hypothermia, Newborn

Body Temperature Changes

Newborn Thermal Injury

Study ID

NCT06230172

Start date

Jul 21, 2023

Status verified date

Feb, 2024

Completion date

Jul 21, 2024

Anticipated

Primary completion date

Jul 21, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Infants with a birth weight <1600 gm

Exclusion Criteria:

  • Infants who have bradycardia (HR<80 bpm) that require stimulation for resolution.
  • Infants who require phototherapy.
  • Infants who require respiratory support >2 liter per minute flow by nasal cannula, oxygen need can vary between 21-100%.
  • Infants with major congenital anomalies

Study Design

Enrollment

50 participants

Anticipated

Intervention Model

Single group

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Prospective group (>1600 grams)

The prospective group is weaned from incubator to crib at a postnatal weight of >1600 grams following consent process.

Interventions

Weaning incubator (heat) at an lower postnatal weight

Infants in the intervention group are weaned in the same manner as the infants in the control arm; however, the wean begins at a lower postnatal weight.

Our institutional guidelines for weaning infants from incubator to crib was unchanged for both groups.

Primary outcome measure

  • Length of hospital stay [ Time Frame: From birth date to hospital discharge, assessed up to 52 weeks ]

Central Contacts and Locations

Central contacts

Victor M Ayulo, MD

9128162144vayulo@augusta.edu

Locations

Augusta University

Recruiting

Augusta, Georgia, United States, 30912

Contacts

Victor M Ayulo, MD

912-816-2144vayulo@augusta.edu

More Information

Sponsor

Augusta University

Last update posted

Feb 7, 2024

Last verified

Feb, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Augusta University on 2024-02-07.