Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting
Trial record 3 of 1636 for:    gastrointestinal | Open Studies | United States

Breast Milk and Congenital Gastrointestinal Disorders

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2016 by Emory University
Sponsor:
Information provided by (Responsible Party):
Megan Durham, Emory University
ClinicalTrials.gov Identifier:
NCT02567292
First received: October 1, 2015
Last updated: October 12, 2016
Last verified: October 2016
  Purpose
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 Intervention
Congenital Gastrointestinal Disorders
Other: Breast Milk

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Effects of an All Breast Milk Diet on Enteral Feeding Outcomes of Neonates With Congenital Gastrointestinal Disorders

Resource links provided by NLM:


Further study details as provided by Emory University:

Primary Outcome Measures:
  • Length of hospital stay [ Time Frame: Post initial feeding (Up to ten days) ] [ Designated as safety issue: No ]
    The length of hospital stay described as the number of days spent in the hospital after the initial breast milk feeding.


Secondary Outcome Measures:
  • Time to full enteral feeding [ Time Frame: Post initial feeding (Up to ten days) ] [ Designated as safety issue: No ]
    The number of days to achieve full enteral feeding after the initial breast milk feeding.

  • Number of days of parenteral nutrition [ Time Frame: Post initial feeding (Up to ten days) ] [ Designated as safety issue: No ]
    The total number of days parenteral nutrition is required.

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

  • Number of sepsis episodes [ Time Frame: Post initial feeding (Up to ten days) ] [ Designated as safety issue: No ]
    The number of sepsis episodes will be compared between the non-breast milk diet (retrospective control group) and the breast milk diet group.

  • Death rate [ Time Frame: Post initial feeding (Up to ten days) ] [ Designated as safety issue: No ]
    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).


Estimated Enrollment: 100
Study Start Date: May 2015
Estimated Study Completion Date: April 2018
Estimated Primary Completion Date: April 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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).

  Eligibility

Ages Eligible for Study:   Child, Adult, Senior
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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 
Study First Received: October 1, 2015
Last Updated: October 12, 2016
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on December 09, 2016