Early Weaning From Incubator To Crib

NCT06230172 | Recruiting DMC FDA Device

• 1 other identifier: 1944411
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Length of hospital stay

  Duration of hospital stay

  From birth date to hospital discharge, assessed up to 52 weeks

Secondary Outcomes (1)

• Growth velocity

  From birth date to hospital discharge, assessed up to 52 weeks

Study Arms (1)

Prospective group (>1600 grams)

EXPERIMENTAL

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

Interventions

Weaning incubator (heat) at an lower postnatal weight RADIATION

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.

Prospective group (>1600 grams)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Infants with a birth weight \<1600 gm

You may not qualify if:

• 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

Sponsors & Collaborators

• Augusta University: lead

Study Sites (1)

Augusta University

Augusta, Georgia, 30912, United States

RECRUITING

Related Publications (2)

• 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.

  PMID: 20696729 BACKGROUND

• 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.

  PMID: 30337189 BACKGROUND

MeSH Terms

Conditions

Hypothermia; Body Temperature Changes

Interventions

Hot Temperature

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Temperature; Thermodynamics; Physical Phenomena; Weather; Atmosphere; Environment; Ecological and Environmental Phenomena; Biological Phenomena; Meteorological Concepts; Environment and Public Health

Central Study Contacts

Victor M Ayulo, MD

CONTACT

9128162144; vayulo@augusta.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: October 4, 2023
• First Posted: January 30, 2024
• Study Start: July 21, 2023
• Primary Completion: July 21, 2024
• Study Completion: July 21, 2024
• Last Updated: February 7, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)