GastroschisisGAINNCT06878950
Early Feeds in Gastroschisis
A study testing Early Feeding Protocol in people with Gastroschisis, run by University of California, Davis at 2 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 0 days to 1 year
- Conditions the study is for
- Gastroschisis
- What is being tested?
- Early Feeding Protocol
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 2 sitesUnited States
- Study dates
- 24 Feb 2025to 1 Feb 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 days to 1 year
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Neonates with presumed simple gastroschisis
- 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
Who cannot join
- Neonates with evidence of complex gastroschisis at time of closure (any ischemic bowel, intestinal perforation, or obvious atresia with mesenteric defect)
- 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)
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Not yet recruiting
University of California Los Angeles
Los Angeles, California, 90095
Kara Calkins, MD, kcalkins@mednet.ucla.edu
Dan Deugarte, MD, ddeugarte@mednet.ucla.edu
- Recruiting
UC Davis Children's Hospital
Sacramento, California, 95817
Nicole Cacho, DO, 916-282-2507
Geoanna Bautista, MD
About this study
Official title: The GAIN Study: The Gastroschisis And Early Infant Nutrition Study
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.
- Conditions
- Gastroschisis
- Being tested
- Early Feeding Protocol
- Keywords
- Gastroschisis, Early feeds in Gastroschisis
- Medical subject headings
- Gastroschisis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early Feeding ProtocolProcedure or surgery
Also called Early Initiation of Human Milk Feeds
The intervention includes removal of Replogle within 24 hours of abdominal closure and the initiation of introductory feeds within 48 hours of abdominal closure.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Early Feeding Protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of Enrollment in Early Feeding Study Cohort
Proportion of eligible neonates with gastroschisis whose parents/guardians consent to enrollment in the study.
Measured: From prenatal period within the first 24 hours of abdominal closure
Secondary outcomes (3)
Feasibility of Protocol Adherence
Proportion of enrolled neonates who are initiated on introductory feeds within 48 hours of abdominal closure.
Measured: From abdominal closure to 48 hours after closure.
Fidelity to Protocol
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.
Measured: From abdominal closure through discharge from the hospital, average of 90 days
Protocol Withdrawal Rate
Proportion of enrolled infants who withdraw from the study
Measured: From time of enrollment (prenatal) to hospital discharge, an average of 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2025
- Study start24 Feb 2025
- Primary completion1 Feb 2028 (estimated)
- Study completion1 Feb 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for GastroschisisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- The study evaluates the feasibility and safety of a standardized early feeding protocol for neonates with presumed simple gastroschisis
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Collaborators
- The Gerber Foundation, University of California, Los Angeles, University of California Fetal Consortium, National Center for Advancing Translational Sciences (NCATS)
- Responsible party
- Sponsor
- Investigators
- Nicole Cacho, DO, Principal investigator, University of California, DavisGeoanna Bautista, MD, Principal investigator, University of California, Davis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06878950
- Sponsor's protocol ID
- 2216195
- Other IDs
- UL1TR001860
- Acronym
- GAIN
- Status last verified
- Mar 2026
- First submitted
- 4 Mar 2025
- Last updated
- 17 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 31801489DeUgarte 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.
PubMed 31704046Jyoti 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.
PubMed 39206671Cacho 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.
PubMed 42298737
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The GAIN Study: The Gastroschisis And Early Infant Nutrition Study
- ClinicalTrials.gov ID
- NCT06878950
- Acronym / sponsor ID
- GAIN / 2216195
- Conditions
- Gastroschisis
- Keywords
- Gastroschisis, Early feeds in Gastroschisis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Collaborators
- The Gerber Foundation, University of California, Los Angeles, University of California Fetal Consortium, National Center for Advancing Translational Sciences (NCATS)
- Study start
- 24 Feb 2025 (actual)
- Primary completion
- 1 Feb 2028 (estimated)
- Study completion
- 1 Feb 2029 (estimated)
- First posted
- 17 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The study evaluates the feasibility and safety of a standardized early feeding protocol for neonates with presumed simple gastroschisis
| Arm | Type | Receives |
|---|---|---|
| Early Feeding Protocol Group | Experimental | Procedure: Early Feeding ProtocolThis 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. |
Who may qualify
- Ages
- 0 days to 1 year
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Neonates with presumed simple gastroschisis
- Born at ≥ 34 weeks' gestation
- Hemodynamically stable
- Consented within 48 hours after abdominal closure
- Mothers who are ≥16 years old
Key exclusion criteria (7 listed)
- Neonates with evidence of complex gastroschisis at time of closure (any ischemic bowel, intestinal perforation, or obvious atresia with mesenteric defect)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Early Feeding ProtocolAlso: Early Initiation of Human Milk FeedsThe intervention includes removal of Replogle within 24 hours of abdominal closure and the initiation of introductory feeds within 48 hours of abdominal closure. | Procedure or surgery | Early Feeding Protocol Group |
Primary outcome
Feasibility of Enrollment in Early Feeding Study Cohort
Time frame: From prenatal period within the first 24 hours of abdominal closure
Proportion of eligible neonates with gastroschisis whose parents/guardians consent to enrollment in the study.
3 secondary outcomes
Feasibility of Protocol Adherence
Time frame: From abdominal closure to 48 hours after closure.
Fidelity to Protocol
Time frame: From abdominal closure through discharge from the hospital, average of 90 days
Protocol Withdrawal Rate
Time frame: From time of enrollment (prenatal) to hospital discharge, an average of 90 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2026.
- Background: PubMed 31801489Hobson 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.
- Background: PubMed 31704046DeUgarte 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.
- Background: PubMed 39206671Jyoti 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.
- Derived from this study: PubMed 42298737Cacho 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.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Nicole Cacho, DO principal investigator
University of California, Davis
Geoanna Bautista, MD principal investigator
University of California, Davis
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Early Feeding Protocol in people with Gastroschisis, run by University of California, Davis at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nicole Cacho, DO ((916) 282-2507, ntcacho@ucdavis.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of Enrollment in Early Feeding Study Cohort (time frame: From prenatal period within the first 24 hours of abdominal closure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06878950, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2026.