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Trial record 5 of 1767 for:    gastrointestinal | Recruiting, Not yet recruiting, Available Studies | United States

Breast Milk and Congenital Gastrointestinal Disorders

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02567292
Recruitment Status : Recruiting
First Posted : October 2, 2015
Last Update Posted : November 1, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
This study aims to identify whether an all breast milk (BM) diet would improve outcomes in neonates with congenital gastrointestinal disorders (CGD) by facilitating an earlier transition off of parenteral nutrition (PN).

Condition or disease Intervention/treatment
Congenital Gastrointestinal Disorders Other: Breast Milk

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Effects of an All Breast Milk Diet on Enteral Feeding Outcomes of Neonates With Congenital Gastrointestinal Disorders
Study Start Date : May 2015
Estimated Primary Completion Date : April 2019
Estimated Study Completion Date : April 2019

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
No Intervention: Retrospective Control Group
Approximately 45 patients with congenital gastrointestinal disorders who were treated in the neonatal intensive care unit (NICU) at Children's Healthcare of Atlanta-Egleston from 2012 to 2015, who had non-breast milk (BM) diets will be identified as retrospective controls using the electronic medical records system.
Experimental: Prospective Breast Milk Group
Approximately 45 participants with congenital gastrointestinal disorders who are admitted to the neonatal intensive care unit (NICU) will have an exclusively breast milk (BM) diet, fortified with Prolacta if required.
Other: Breast Milk
Participants will receive breast milk (fortified with Prolacta if required per doctor's discretion) for regular feedings while in the neonatal intensive care unit (NICU).


Outcome Measures

Primary Outcome Measures :
  1. Length of hospital stay [ Time Frame: Post initial feeding (Up to ten days) ]
    The length of hospital stay described as the number of days spent in the hospital after the initial breast milk feeding.


Secondary Outcome Measures :
  1. Time to full enteral feeding [ Time Frame: Post initial feeding (Up to ten days) ]
    The number of days to achieve full enteral feeding after the initial breast milk feeding.

  2. Number of days of parenteral nutrition [ Time Frame: Post initial feeding (Up to ten days) ]
    The total number of days parenteral nutrition is required.

  3. Difference in bilirubin levels [ Time Frame: Post initial feeding (Up to ten days) ]
    The difference in average bilirubin level will be compared between the non-breast milk diet (retrospective control group) and the breast milk diet group.

  4. Number of sepsis episodes [ Time Frame: Post initial feeding (Up to ten days) ]
    The number of sepsis episodes will be compared between the non-breast milk diet (retrospective control group) and the breast milk diet group.

  5. Death rate [ Time Frame: Post initial feeding (Up to ten days) ]
    The number of deaths between participants who receive breast milk only diets as compared to the non-breast milk diet (retrospective control group while in the neonatal intensive care unit (NICU).


Eligibility Criteria

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Neonates admitted to the Egleston Neonatal intensive care unit (NICU) who have never been fed
  • Congenital gastrointestinal abnormalities such as gastroschisis, bowel atresias, malrotation, omphalocele, or meconium ileus

Exclusion Criteria:

  • Previous feeding
Contacts and Locations

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): NCT02567292


Contacts
Contact: Megan Durham, MD 404-785-8787 megan.durham@emory.edu

Locations
United States, Georgia
Children's Healthcare of Atlanta-Egleston Recruiting
Atlanta, Georgia, United States, 30329
Contact: Megan Durham, MD    404-727-3779    megan.durham@emory.edu   
Sponsors and Collaborators
Emory University
Investigators
Principal Investigator: Megan Durham, MD Emory University
More Information

Responsible Party: Megan Durham, Associate Professor, Emory University
ClinicalTrials.gov Identifier: NCT02567292     History of Changes
Other Study ID Numbers: IRB00080481
First Posted: October 2, 2015    Key Record Dates
Last Update Posted: November 1, 2017
Last Verified: October 2017

Keywords provided by Megan Durham, Emory University:
Digestive Disease and Disorders
Neonatal
Pediatric Disorders

Additional relevant MeSH terms:
Disease
Digestive System Diseases
Gastrointestinal Diseases
Pathologic Processes