Evidence map›Paper›PMID 42298737›Full record

ArticlePilot and feasibility studies2026

GAIN: a multicenter pilot protocol for early initiation of enteral feeds in neonates with simple gastroschisis.

Nicole T Cacho, Anjali J Cera, Daniel J Tancredi, Minna M Wieck, Jamie E Anderson, Alexandra J Leegwater, Cherry C Uy, Yigit S Guner, Daniel A DeUgarte, Jennifer L Rosenthal and 3 more

Registry-linked trialAbstract read
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In one paragraph

Article in Pilot and feasibility studies, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06878950 (The GAIN Study), which is not on this map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT06878950 narecruitingnot on this map

The GAIN Study: The Gastroschisis And Early Infant Nutrition Study

TypeinterventionalSponsorUniversity of California, DavisRan2025 to 2029Enrolled20ConditionsGastroschisisArmsEarly Feeding Protocol
3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

13 authors.

Nicole T CachoDepartment of Pediatrics, University of California Davis, Sacramento, CA, 95817, USA.
Anjali J CeraDepartment of Pediatrics, Kaiser Permanente, Roseville, CA, 95661, USA.
Daniel J TancrediDepartment of Pediatrics, University of California Davis, Sacramento, CA, 95817, USA.
Minna M WieckDepartment of Surgery, University of California Davis, Sacramento, CA, 95817, USA.
Jamie E AndersonDepartment of Surgery, University of California Davis, Sacramento, CA, 95817, USA.
Alexandra J LeegwaterDepartment of Pediatrics, University of California Davis, Sacramento, CA, 95817, USA.
Cherry C UyDepartment of Pediatrics, University of California, Irvine, Irvine, CA, 92697, USA.
Yigit S GunerDepartment of Surgery, Children's Hospital of Orange County, Orange, CA, 92868, USA.
Daniel A DeUgarteDepartment of Surgery, University of California, Los Angeles, CA, 90095, USA.
Jennifer L RosenthalDepartment of Pediatrics, University of California Davis, Sacramento, CA, 95817, USA.
Kara L CalkinsDepartment of Pediatrics, University of California, Los Angeles, CA, 90095, USA.
Geoanna M BautistaDepartment of Pediatrics, University of California Davis, Sacramento, CA, 95817, USA. gmbautista@health.ucdavis.edu.ORCID http://orcid.org/0000-0003-0245-9272
University of California Fetal Consortium (UCfC)

Funding

UC Davis Clinical and Translational Science CenterUL1TR001860 · NCATS · UNIVERSITY OF CALIFORNIA AT DAVIS · PI KENYON, NICHOLAS J., LYLES, COURTNEY REES · 2016 to 2025
$47.3M
Institutional Career Development Core (KL2)KL2TR001859 · NCATS · UNIVERSITY OF CALIFORNIA AT DAVIS · PI HOLMES, JAMES F. · 2016 to 2025
$10.1M
Smooth Muscle Mechanotransduction: Calcium Dynamics in the Developing GutK08DK143334 · NIDDK · UNIVERSITY OF CALIFORNIA AT DAVIS · PI Geoanna Marie Bautista · 2025 to 2026
$329k
NCATS NIH HHS KL2 TR001859NCATS NIH HHS UL1 TR001860NIDDK NIH HHS K08 DK143334NIDDK NIH HHS L40 DK137356
6 · The paper itself

Abstract

backgroundGastroschisis is a congenital abdominal wall defect characterized by severe gut dysmotility. These neonates often face lengthy hospital stays, prolonged parenteral nutrition dependence, and complications such as growth faltering, sepsis, and intestinal failure. Feeding practices for neonates with gastroschisis vary and emphasize extended bowel rest and delayed feeding initiation. Usual practices in determining timing to start feeds include awaiting return of bowel function which typically consists of low Replogle output volume, color changing from bilious to clear and/or passing stool. However, emerging studies suggest that early initiation of feeds through standardized protocols may improve outcomes. The Gastroschisis And Early Infant Nutrition (GAIN) Study aims to test the feasibility of an early feeding approach in neonates with simple gastroschisis.

methodsThis two-site single-arm feasibility trial aims to enroll neonates with presumed simple gastroschisis over 30 months. The intervention has two main components: Replogle suction tube removal within 24 h of abdominal closure and starting small-volume human milk feeds within 48 h of abdominal closure. Feeding volume will be advanced as tolerated, following the University of California Fetal Consortium pathway, which is standard care. Feasibility outcomes include enrollment rate, protocol adherence, fidelity, and withdrawal rate. Exploratory outcomes include hospitalization length, time to full feeds, duration of parenteral nutrition, use of human milk, breastfeeding rates, and anthropometric measurements. Safety measures involve monitoring for feeding-related complications, infections, and unexpected surgical interventions. DISCUSSION: This feasibility trial of early feeding initiation in neonates with gastroschisis is a critical step towards addressing the need for a standardized feeding approach. Findings will inform future clinical trials and challenge the need for prolonged bowel rest. Standardizing early feeding practices could reduce practice variation, improve gut motility, and the overall health of neonates with gastroschisis. SYSTEMATIC REVIEW REGISTRATION: NCT06878950.

Indexed as

Early feedsFeasibility trialGastroschisisNeonatal intensive care unitRare disease

Identifiers

PMID42298737
PMCPMC13495323

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.