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| ID | Type | Description | Link |
|---|---|---|---|
| UL1TR001860 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| The Gerber Foundation | OTHER |
| University of California, Los Angeles | OTHER |
| University of California Fetal Consortium | UNKNOWN |
| National Center for Advancing Translational Sciences (NCATS) |
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This study aims to evaluate the feasibility of initiating early feeds in neonates with gastroschisis, a condition where infants are born with their intestines outside the body.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Early Feeding Protocol Group | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Early Feeding Protocol | Procedure | The intervention includes removal of Replogle within 24 hours of abdominal closure and the initiation of introductory feeds within 48 hours of abdominal closure. |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility of Enrollment in Early Feeding Study Cohort | Proportion of eligible neonates with gastroschisis whose parents/guardians consent to enrollment in the study. | From prenatal period within the first 24 hours of abdominal closure |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility of Protocol Adherence | Proportion of enrolled neonates who are initiated on introductory feeds within 48 hours of abdominal closure. | From abdominal closure to 48 hours after closure. |
| Fidelity to Protocol |
| Measure | Description | Time Frame |
|---|---|---|
| Outcomes of of Adverse Events | This exploratory outcome is measuring the incidence of severe adverse events in neonates enrolled in the early feeding protocol study. Adverse events include:
| From enrollment through hospital discharge, an average of 90 days |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nicole Cacho, DO | Contact | (916) 282-2507 | ntcacho@ucdavis.edu | |
| Geoanna Bautista, MD | Contact | (916) 282-2507 | gmbautista@ucdavis.edu |
| Name | Affiliation | Role |
|---|---|---|
| Nicole Cacho, DO | University of California, Davis | Principal Investigator |
| Geoanna Bautista, MD | University of California, Davis | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California Los Angeles | Not yet recruiting | Los Angeles | California | 90095 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31801489 | Background | 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. | |
| 31704046 | Background | 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. |
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After the primary study results are published, individual participant data will be de-identified and made available to qualified researchers upon request, subject to a data use agreement and review by the study team. Access will be granted within 12 months of a successful application, provided the request aligns with the study's scientific objectives, the intended study is IRB approved and adheres to ethical data protection guidelines.
Starting 6 months after publication
The study team will review application requests submitted by interested researchers. The intended study must align with our study's scientific objectives, be IRB approved, and adhere to ethical data protection guidelines.
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| ID | Term |
|---|---|
| D020139 | Gastroschisis |
| ID | Term |
|---|---|
| D009139 | Musculoskeletal Abnormalities |
| D009140 | Musculoskeletal Diseases |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
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| NIH |
The study evaluates the feasibility and safety of a standardized early feeding protocol for neonates with presumed simple gastroschisis
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Proportion of enrolled infants with gastroschisis who adhere to the remainder of the protocol without major deviations. Feasibility will be assessed using protocol adherence tracking forms completed by study team.
| From abdominal closure through discharge from the hospital, average of 90 days |
| Protocol Withdrawal Rate | Proportion of enrolled infants who withdraw from the study | From time of enrollment (prenatal) to hospital discharge, an average of 90 days |
| Outcomes of Hospital Admission Duration | This exploratory outcome measures the total duration of length (days) of hospital stay. | From birth admission to hospital through discharge, assessed up to 1 year |
| Outcome of Duration of Parenteral Nutrition | This exploratory outcome measures the total duration of parenteral nutrition (days) in enrolled patients. | From initiation of parenteral nutrition through achievement of enteral autonomy, assessed up to 1 year |
| Outcome of Feeding Progression | This exploratory outcome measures the feeding progression (time to first feed (days) and time to full feeds (days)) in infants enrolled. | From initiation of feeds through achievement of enteral autonomy, assessed up to 1 year |
| Outcome of Growth Parameters | This exploratory outcomes measures the changes in growth parameters (height, weight) using calculated z-scores (as measured by standard deviations from the mean, presented in percentages relative to average for age). | From birth admission to hospital through discharge, assessed up to 1 year |
| Feasibility of Data Collection of Direct Breastfeeding Practices | Assessment of the feasibility of obtaining information related to breastfeeding practices through electronic medical records, using dichotomous measures of whether parent had direct breastfeeding during hospitalization and at time of discharge (48 hours prior to hospital discharge). | Assessed from birth through hospital discharge, an average of 90 days |
| UC Davis Children's Hospital | Recruiting | Sacramento | California | 95817 | United States |
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| 39206671 | Background | 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. |
| 42298737 | Derived | Cacho NT, Cera AJ, Tancredi DJ, Wieck MM, Anderson JE, Leegwater AJ, Uy CC, Guner YS, DeUgarte DA, Rosenthal JL, Calkins KL, Bautista GM; University of California Fetal Consortium (UCfC). GAIN: a multicenter pilot protocol for early initiation of enteral feeds in neonates with simple gastroschisis. Pilot Feasibility Stud. 2026 Jun 15. doi: 10.1186/s40814-026-01860-4. Online ahead of print. |
| D046449 | Hernia, Abdominal |
| D006547 | Hernia |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |