GastroschisisNCT02575846
Clinical and Biological Outcomes of Human Milk and Formula Intake After Gastroschisis Repair
A study testing Enteral Intake - Human Milk and Enteral Intake - Formula in people with Gastroschisis, run by Duke University at 1 site in United States.
Trial summary
The purpose of this study is to determine which type of food results in a shorter hospital stay and better overall outcome for babies born with gastroschisis. Read more about this study
- Who is it for?
- Ages 2 to 48 hoursHealthy volunteers can take part
- Conditions the study is for
- Gastroschisis
- What is being tested?
- Enteral Intake - Human Milk and Enteral Intake - Formula
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Nov 2015to 11 Nov 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 2 to 48 hours
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 1) neonates born with gastroschisis
- 2) neonatologist, surgeon, and parent (or care provider) willing to have the neonate participate in the study
Who cannot join
- 1) associated anomaly or medical concern that impacts hospital length of stay (i.e. intestinal atresia, very low birth weight(<1500 grams))
- 2) known major chromosomal abnormality
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Medical Center
Durham, North Carolina, 27710
About this study
The purpose of this study is to determine which type of food results in a shorter hospital stay and better overall outcome for babies born with gastroschisis.
- Conditions
- Gastroschisis
- Being tested
- Enteral Intake - Human Milk, Enteral Intake - Formula
- Medical subject headings
- Gastroschisis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enteral Intake - Human MilkDietary supplement
Comparing formula and human milk
Enteral Intake - FormulaDietary supplement
Comparing formula and human milk
| Study group | Role | What they receive |
|---|---|---|
| Human Milk | Active comparator | Neonates fed human milk Receives: Dietary Supplement: Enteral Intake - Human Milk |
| Formula | Placebo comparator | Neonates fed formula Receives: Dietary Supplement: Enteral Intake - Formula |
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of Hospital Stay
Measured: One month
Secondary outcomes (2)
Time to Full Enteral Feeds
Measured: Three weeks
Time on Total Parenteral Nutrition
Measured: Three weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2015 (estimated)
- Study start26 Nov 2015
- Primary completion11 Nov 2016
- Study completion11 Nov 2016
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.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Obinna O Adibe, MD, MHS, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02575846
- Sponsor's protocol ID
- Pro00056976
- Status last verified
- Jun 2017
- First submitted
- 6 Oct 2015
- Last updated
- 12 Apr 2024
- Results posted
- No
Publications
Kohler JA Sr, Perkins AM, Bass WT. Human milk versus formula after gastroschisis repair: effects on time to full feeds and time to discharge. J Perinatol. 2013 Aug;33(8):627-30. doi: 10.1038/jp.2013.27. Epub 2013 Mar 21.
PubMed 23519369Sydorak RM, Nijagal A, Sbragia L, Hirose S, Tsao K, Phibbs RH, Schmitt SK, Lee H, Farmer DL, Harrison MR, Albanese CT. Gastroschisis: small hole, big cost. J Pediatr Surg. 2002 Dec;37(12):1669-72. doi: 10.1053/jpsu.2002.36689.
PubMed 12483626Mastromarino P, Capobianco D, Campagna G, Laforgia N, Drimaco P, Dileone A, Baldassarre ME. Correlation between lactoferrin and beneficial microbiota in breast milk and infant's feces. Biometals. 2014 Oct;27(5):1077-86. doi: 10.1007/s10534-014-9762-3. Epub 2014 Jun 27.
PubMed 24970346Gomez-Llorente C, Plaza-Diaz J, Aguilera M, Munoz-Quezada S, Bermudez-Brito M, Peso-Echarri P, Martinez-Silla R, Vasallo-Morillas MI, Campana-Martin L, Vives-Pinera I, Ballesta-Martinez MJ, Gil A. Three main factors define changes in fecal microbiota associated with feeding modality in infants. J Pediatr Gastroenterol Nutr. 2013 Oct;57(4):461-6. doi: 10.1097/MPG.0b013e31829d519a.
PubMed 23752082
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Biological Outcomes of Human Milk and Formula Intake After Gastroschisis Repair
- ClinicalTrials.gov ID
- NCT02575846
- Acronym / sponsor ID
- Pro00056976
- Conditions
- Gastroschisis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- 26 Nov 2015 (actual)
- Primary completion
- 11 Nov 2016 (actual)
- Study completion
- 11 Nov 2016 (actual)
- First posted
- 15 Oct 2015 (estimated)
- 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.
The purpose of this study is to determine which type of food results in a shorter hospital stay and better overall outcome for babies born with gastroschisis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Human Milk | Active comparator | Dietary Supplement: Enteral Intake - Human MilkNeonates fed human milk |
| Formula | Placebo comparator | Dietary Supplement: Enteral Intake - FormulaNeonates fed formula |
Who may qualify
- Ages
- 2 to 48 hours
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 1) neonates born with gastroschisis
- 2) neonatologist, surgeon, and parent (or care provider) willing to have the neonate participate in the study
Key exclusion criteria (2 listed)
- 1) associated anomaly or medical concern that impacts hospital length of stay (i.e. intestinal atresia, very low birth weight(<1500 grams))
- 2) known major chromosomal abnormality
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 |
|---|---|---|
| Enteral Intake - Human MilkComparing formula and human milk | Dietary supplement | Human Milk |
| Enteral Intake - FormulaComparing formula and human milk | Dietary supplement | Formula |
Primary outcome
Length of Hospital Stay
Time frame: One month
2 secondary outcomes
Time to Full Enteral Feeds
Time frame: Three weeks
Time on Total Parenteral Nutrition
Time frame: Three weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2024.
- Background: PubMed 23519369Kohler JA Sr, Perkins AM, Bass WT. Human milk versus formula after gastroschisis repair: effects on time to full feeds and time to discharge. J Perinatol. 2013 Aug;33(8):627-30. doi: 10.1038/jp.2013.27. Epub 2013 Mar 21.
- Background: PubMed 12483626Sydorak RM, Nijagal A, Sbragia L, Hirose S, Tsao K, Phibbs RH, Schmitt SK, Lee H, Farmer DL, Harrison MR, Albanese CT. Gastroschisis: small hole, big cost. J Pediatr Surg. 2002 Dec;37(12):1669-72. doi: 10.1053/jpsu.2002.36689.
- Background: PubMed 24970346Mastromarino P, Capobianco D, Campagna G, Laforgia N, Drimaco P, Dileone A, Baldassarre ME. Correlation between lactoferrin and beneficial microbiota in breast milk and infant's feces. Biometals. 2014 Oct;27(5):1077-86. doi: 10.1007/s10534-014-9762-3. Epub 2014 Jun 27.
- Background: PubMed 23752082Gomez-Llorente C, Plaza-Diaz J, Aguilera M, Munoz-Quezada S, Bermudez-Brito M, Peso-Echarri P, Martinez-Silla R, Vasallo-Morillas MI, Campana-Martin L, Vives-Pinera I, Ballesta-Martinez MJ, Gil A. Three main factors define changes in fecal microbiota associated with feeding modality in infants. J Pediatr Gastroenterol Nutr. 2013 Oct;57(4):461-6. doi: 10.1097/MPG.0b013e31829d519a.
Related trials for Gastroschisis
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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. This study is not recruiting at the moment.
Obinna O Adibe, MD, MHS principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Enteral Intake - Human Milk and Enteral Intake - Formula in people with Gastroschisis, run by Duke University at 1 site 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 2 inclusion and 2 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: finished, as of the sponsor's last update on 12 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Length of Hospital Stay (time frame: One month). 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 NCT02575846, 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 12 Apr 2024.