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Early Weaning From Incubator To Crib

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Augusta University

Status

Enrolling

Conditions

Body Temperature Changes
Hypothermia, Newborn
Newborn Thermal Injury

Treatments

Radiation: Weaning incubator (heat) at an lower postnatal weight

Study type

Interventional

Funder types

Other

Identifiers

NCT06230172
1944411

Details and patient eligibility

About

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.

Enrollment

50 estimated patients

Sex

All

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Supportive Care

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

50 participants in 1 patient group

Prospective group (>1600 grams)
Experimental group
Description:
The prospective group is weaned from incubator to crib at a postnatal weight of \>1600 grams following consent process.
Treatment:
Radiation: Weaning incubator (heat) at an lower postnatal weight

Trial contacts and locations

1

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Central trial contact

Victor M Ayulo, MD

Data sourced from clinicaltrials.gov

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