An interventional study of Weaning incubator (heat) at an lower postnatal weight in Hypothermia, Newborn, Body Temperature Changes and Newborn Thermal Injury, sponsored by Augusta University. Recruiting at 1 site in United States. Per ClinicalTrials.gov, last updated 2024-02-07.
Sponsored by Augusta University · Not applicable, Interventional, and Supportive care
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.
449 studies on the registry are indexed under Hypothermia; 54 are open to participants now.
This study's planned enrollment of 50 is below the median of 77 across 328 interventional studies indexed under Hypothermia.
Browse Hypothermia studies →Augusta University is the lead sponsor of 180 studies on the registry; 24 are open to participants now.
Of its 10 completed or terminated interventional studies of FDA-regulated products, 3 (30%) have results posted.
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Exclusion Criteria:
The prospective group is weaned from incubator to crib at a postnatal weight of \>1600 grams following consent process.
Radiation: 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.
Length of hospital stay
Duration of hospital stay
Time frame: From birth date to hospital discharge, assessed up to 52 weeks
Growth velocity
Weight gain following wean from incubator to crib
Time frame: From birth date to hospital discharge, assessed up to 52 weeks
Plan to share: No
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