Human Milk for Congenital Gastrointestinal Disorders (HM for CGD)
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|ClinicalTrials.gov Identifier: NCT02567292|
Recruitment Status : Recruiting
First Posted : October 2, 2015
Last Update Posted : August 27, 2019
|Condition or disease||Intervention/treatment||Phase|
|Congenital Gastrointestinal Disorders||Other: Human Milk||Not Applicable|
Infants born with congenital gastrointestinal disorders (CGD) can be very challenging to treat. The CGD require surgery shortly after birth to correct the problems and recovery can take a long time.
During the period of time the infant's intestines are sick or don't work properly, they rely on parenteral nutrition (IV fluids containing carbohydrates, proteins and fats) to meet their nutritional needs. Being on PN for a long time requires special intravenous lines, and increases the risk of blood stream infections and can make the liver sick.
Feeding babies who have these CGD is often very difficult, as the intestine needs to adapt. It needs to make appropriately formed stool to eliminate wastes, but not lose too much water or too many electrolytes. There is often a lot of starting and stopping of feeds. Human milk (HM) is considered the ideal source of nutrition for all infants.
This study aims to identify whether an exclusive human milk diet (EHMD) would improve outcomes in neonates with congenital gastrointestinal disorders (CGD) and by facilitating an earlier transition off of parenteral nutrition (PN).
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||150 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Effects of an Exclsuive Human Milk Diet on Enteral Feeding Outcomes of Neonates With Congenital Gastrointestinal Disorders|
|Actual Study Start Date :||July 26, 2018|
|Estimated Primary Completion Date :||May 31, 2020|
|Estimated Study Completion Date :||April 30, 2021|
No Intervention: Retrospective Control Group
Approximately 150 patients with congenital gastrointestinal disorders who were treated in the neonatal intensive care unit (NICU) at Children's Healthcare of Atlanta-Egleston and other participating institutions from 2012 to 2015, who had non-human milk (HM) diets will be identified as retrospective controls using the electronic medical records system.
Experimental: Exclusive Human Milk Diet Group
A minimum of 150 patients with CGD admitted to participating NICUs who meet inclusion criteria and provide informed consent will be enrolled in the prospective arm of the study. These patients will be fed an EHMD comprised of mother's own milk (MOM) or pasteurized donor human milk (DM). Fortification will be provided with human milk derived human milk fortifier, either a human milk-based fortifier (Prolact+ H2MF®) for infants born at less than 37 weeks GA or <2,200g birth weight or the term-equivalent version (PBCLN-002) formulated for infants >37 weeks and/or >2,200g at birth. Infants will receive this EHMD until they have achieved full enteral feedings for 7 days with bowel in continuity
Other: Human Milk
Participants will receive an exclusive human milk diet comprised of mother's own milk (MOM, pasteurized donor human milk (DM) fortified with a donor-milk based fortifier (DMBF): Prolact+ for infants <37 weeks PMA and/or or weight <2,200g or PBCLN-002 for infants >37 weeks PMA and/or weight >2,200g)
- Time to full enteral feeding [ Time Frame: From birth to day of life full enteral feedings for 7 days is achieved (up to 30 days) ]The number of days to achieve full enteral feeding after the initial human milk feeding
- Number of days of parenteral nutrition [ Time Frame: Through study completion, up to 1 year ]The total number of days parenteral nutrition is required.
- Length of hospital stay [ Time Frame: Through study completion, up to 6 months ]The length of hospital stay described as the number of days spent in the hospital
- Difference in conjugated bilirubin levels [ Time Frame: From birth to day of life full enteral feedings for 7 days is achieved (up to 30 days) ]The difference in average bilirubin level will be compared between the non-human milk diet (retrospective control group) and the breast milk diet group.
- Feeding intolerance [ Time Frame: From birth to day of life full enteral feedings for 7 days is achieved (up to 30 days) ]Number of days when one or more feedings were held for clinical concerns
- Feeding interruptions [ Time Frame: From birth to day of life full enteral feedings for 7 days is achieved (up to 30 days) ]NPO for at least 24 hours. NPO due to elective surgeries or procedures will not be defined as feeding interruptions
- Episodes of Necrotizing Enterocolitis [ Time Frame: From birth to day of life full enteral feedings for 7 days is achieved (up to 30 days) ]Number of episodes of Stage IIb NEC or greater
- Number of sepsis episodes [ Time Frame: From birth to day of life full enteral feedings for 7 days is achieved (up to 30 days) ]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: Through study completion, up to 1 year ]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).
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
|Contact: Heidi Karpen, MDfirstname.lastname@example.org|
|Contact: Megan Durham, MDemail@example.com|
|United States, Georgia|
|Children's Healthcare of Atlanta-Egleston||Recruiting|
|Atlanta, Georgia, United States, 30322|
|Contact: Heidi E Karpen, MD 404-727-3375 firstname.lastname@example.org|
|Contact: Megan Durham, MD 4047858787 email@example.com|
|Principal Investigator:||Heidi Karpen, MD||Emory University|