Early Weaning From Incubator To Crib

Body Temperature Changes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06230172
• Other study ID #: 1944411
• Status: Recruiting
• Phase: N/A
• Start date: July 21, 2023
• Est. completion date: July 21, 2024

Study information

• Verified date: February 2024
• Source: Augusta University
• Contact: Victor M Ayulo, MD
• Phone: 9128162144
• Email: vayulo[@]augusta.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: July 21, 2024
• Est. primary completion date: July 21, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Body Temperature Changes
• Hypothermia
• Hypothermia, Newborn

Intervention

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.

Locations

Country	Name	City	State
United States	Augusta University	Augusta	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
Augusta University

Country where clinical trial is conducted

United States, 

References & Publications (2)

Shankaran S, Bell EF, Laptook AR, Saha S, Newman NS, Kazzi SNJ, Barks J, Stoll BJ, Bara R, Gabrio J, Childs K, Das A, Higgins RD, Carlo WA, Sanchez PJ, Carlton DP, Pavageau L, Malcolm WF, D'Angio CT, Ohls RK, Poindexter BB, Sokol GM, Van Meurs KP, Colaizy TT, Khmour A, Puopolo KM, Garg M, Walsh MC; Eunice Kennedy Shriver National Institute of Child Health, and Human Development Neonatal Research Network. Weaning of Moderately Preterm Infants from the Incubator to the Crib: A Randomized Clinical Trial. J Pediatr. 2019 Jan;204:96-102.e4. doi: 10.1016/j.jpeds.2018.08.079. Epub 2018 Oct 15. Erratum In: J Pediatr. 2020 Mar;218:e5. — View Citation

Zecca E, Corsello M, Priolo F, Tiberi E, Barone G, Romagnoli C. Early weaning from incubator and early discharge of preterm infants: randomized clinical trial. Pediatrics. 2010 Sep;126(3):e651-6. doi: 10.1542/peds.2009-3005. Epub 2010 Aug 9. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Length of hospital stay	Duration of hospital stay	From birth date to hospital discharge, assessed up to 52 weeks
Secondary	Growth velocity	Weight gain following wean from incubator to crib	From birth date to hospital discharge, assessed up to 52 weeks