Study Results
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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RECRUITING
NA
50 participants
INTERVENTIONAL
2023-07-21
2024-07-21
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
SUPPORTIVE_CARE
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.
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.
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.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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
ALL
No
Sponsors
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Augusta University
OTHER
Responsible Party
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Locations
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Augusta University
Augusta, Georgia, United States
Countries
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Central Contacts
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Facility Contacts
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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.
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.
Other Identifiers
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1944411
Identifier Type: -
Identifier Source: org_study_id
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