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Early Weaning From Incubator To Crib

Early Weaning of Infants Less Than 1800 Grams From Incubator To Crib

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06230172
Enrollment
50
Registered
2024-01-30
Start date
2023-07-21
Completion date
2024-07-21
Last updated
2024-02-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Body Temperature Changes, Hypothermia, Newborn, Newborn Thermal Injury

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.

Interventions

RADIATIONWeaning 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.

Sponsors

Augusta University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Intervention model description

The investigators will compare a retrospective control arm with a prospective intervention arm.

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Length of hospital stayFrom birth date to hospital discharge, assessed up to 52 weeksDuration of hospital stay

Secondary

MeasureTime frameDescription
Growth velocityFrom birth date to hospital discharge, assessed up to 52 weeksWeight gain following wean from incubator to crib

Countries

United States

Contacts

Primary ContactVictor M Ayulo, MD
vayulo@augusta.edu9128162144

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026