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Trial record 9 of 31 for:    "Gastroschisis"

Clinical and Biological Outcomes of Human Milk and Formula Intake After Gastroschisis Repair

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02575846
Recruitment Status : Completed
First Posted : October 15, 2015
Last Update Posted : June 28, 2017
Sponsor:
Information provided by (Responsible Party):
Duke University

Brief 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.

Condition or disease Intervention/treatment Phase
Gastroschisis Dietary Supplement: Enteral Intake - Human Milk Dietary Supplement: Enteral Intake - Formula Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clinical and Biological Outcomes of Human Milk and Formula Intake After Gastroschisis Repair
Actual Study Start Date : November 26, 2015
Actual Primary Completion Date : November 11, 2016
Actual Study Completion Date : November 11, 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Human Milk
Neonates fed human milk
Dietary Supplement: Enteral Intake - Human Milk
Comparing formula and human milk

Placebo Comparator: Formula
Neonates fed formula
Dietary Supplement: Enteral Intake - Formula
Comparing formula and human milk




Primary Outcome Measures :
  1. Length of Hospital Stay [ Time Frame: One month ]

Secondary Outcome Measures :
  1. Time to Full Enteral Feeds [ Time Frame: Three weeks ]
  2. Time on Total Parenteral Nutrition [ Time Frame: Three weeks ]


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Ages Eligible for Study:   up to 48 Hours   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 1) neonates born with gastroschisis
  • 2) neonatologist, surgeon, and parent (or care provider) willing to have the neonate participate in the study

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02575846


Locations
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United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
Duke University
Investigators
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Principal Investigator: Obinna O Adibe, MD, MHS Duke University

Publications:
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Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT02575846     History of Changes
Other Study ID Numbers: Pro00056976
First Posted: October 15, 2015    Key Record Dates
Last Update Posted: June 28, 2017
Last Verified: June 2017

Additional relevant MeSH terms:
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Gastroschisis
Musculoskeletal Abnormalities
Musculoskeletal Diseases
Congenital Abnormalities
Hernia, Abdominal
Hernia
Pathological Conditions, Anatomical