Early Weaning From Incubator To Crib

NCT ID: NCT06230172

Last Updated: 2024-02-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-07-21

Study Completion Date

2024-07-21

Brief Summary

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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.

Detailed Description

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Conditions

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Hypothermia, Newborn Body Temperature Changes Newborn Thermal Injury

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Prospective group (>1600 grams)

The prospective group is weaned from incubator to crib at a postnatal weight of \>1600 grams following consent process.

Group Type EXPERIMENTAL

Weaning incubator (heat) at an lower postnatal weight

Intervention Type 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.

Interventions

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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.

Intervention Type RADIATION

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Augusta University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Augusta University

Augusta, Georgia, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Victor M Ayulo, MD

Role: CONTACT

9128162144

Facility Contacts

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Victor M Ayulo, MD

Role: primary

912-816-2144

References

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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.

Reference Type BACKGROUND
PMID: 20696729 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30337189 (View on PubMed)

Other Identifiers

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1944411

Identifier Type: -

Identifier Source: org_study_id

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