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
20 participants
INTERVENTIONAL
2025-02-24
2029-02-01
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
TREATMENT
NONE
Study Groups
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Early Feeding Protocol Group
This arm involves neonates with presumed simple gastroschisis who will be subjected to an early feeding protocol. The protocol specifies initiating human milk feeds within 48 hours of surgical repair of gastroschisis. Feeds are advanced based on tolerance and clinical assessment, with a focus on promoting oral motor skill development.
Early Feeding Protocol
The intervention includes removal of Replogle within 24 hours of abdominal closure and the initiation of introductory feeds within 48 hours of abdominal closure.
Interventions
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Early Feeding Protocol
The intervention includes removal of Replogle within 24 hours of abdominal closure and the initiation of introductory feeds within 48 hours of abdominal closure.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Born at ≥ 34 weeks' gestation
* Hemodynamically stable
* Consented within 48 hours after abdominal closure
* Mothers who are ≥16 years old
* Mothers who speak English or Spanish
Exclusion Criteria
* Presence of any major congenital anomalies
* Neonates who are receiving ionotropic medications
* Neonates who are wards of the state
* Neonates whose care is considered to be futile or those undergoing re-direction of care
* Neonates participating in another interventional trial
* Any patient deemed unfit for participation by study investigator(s)
0 Days
1 Year
ALL
No
Sponsors
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The Gerber Foundation
OTHER
University of California, Los Angeles
OTHER
University of California Fetal Consortium
UNKNOWN
National Center for Advancing Translational Sciences (NCATS)
NIH
University of California, Davis
OTHER
Responsible Party
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Principal Investigators
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Nicole Cacho, DO
Role: PRINCIPAL_INVESTIGATOR
University of California, Davis
Geoanna Bautista, MD
Role: PRINCIPAL_INVESTIGATOR
University of California, Davis
Locations
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University of California Los Angeles
Los Angeles, California, United States
UC Davis Children's Hospital
Sacramento, California, United States
Countries
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Central Contacts
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Facility Contacts
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Nicole Cacho, DO
Role: primary
Geoanna Bautista, MD
Role: backup
References
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Hobson D, Spence K, Trivedi A, Thomas G. Differences in attitudes to feeding post repair of Gastroschisis and development of a standardized feeding protocol. BMC Pediatr. 2019 Dec 4;19(1):475. doi: 10.1186/s12887-019-1858-z.
DeUgarte DA, Calkins KL, Guner Y, Kim J, Kling K, Kramer K, Lee H, Lusk L, Saadai P, Uy C, Rottkamp C; University of California Fetal Consortium. Adherence to and outcomes of a University-Consortium gastroschisis pathway. J Pediatr Surg. 2020 Jan;55(1):45-48. doi: 10.1016/j.jpedsurg.2019.09.048. Epub 2019 Oct 27.
Jyoti J, James-Nunez K, Spence K, Parkinson B, Thomas G, Trivedi A. Evaluation of gastroschisis feeding protocol: A retrospective cohort study. J Paediatr Child Health. 2024 Nov;60(11):675-679. doi: 10.1111/jpc.16657. Epub 2024 Aug 29.
Other Identifiers
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2216195
Identifier Type: -
Identifier Source: org_study_id
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