Congenital Gastrointestinal Disorders
Conditions
Keywords
Digestive Disease and Disorders, Neonatal, Pediatric Disorders
Brief summary
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).
Detailed description
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).
Interventions
OTHERHuman 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)
Sponsors
Chatham Valley Foundation
Prolacta Bioscience
Emory University
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
1 Minutes to 1 Years
Healthy volunteers
No
Inclusion criteria
1. Admission to participating NICU at less than 7 days of age 2. Birthweight \>1250g and/or gestational age at birth \>32 weeks 3. Less than 7 days of enteral feedings 4. Diagnosis of eligible primary Congenital Gastointestinal Disorders defined as: gastroschisis, omphalocele and intestinal atresias 5. Consent to the use of donor human milk products 6. Consent to participate in this study
Exclusion criteria
1. Admission to participating NICU at \>7 days of age 2. Birthweight \<1250g and/or gestational age \<32 weeks 3. Diagnosis of non-eligible gastrointestinal disorders: congenital diaphragmatic hernia, midgut volvulus, Hirschsprung's disease, esophageal atresia, imperforate anus 4. Evidence of significant liver dysfunction at time of enrollment (direct bilirubin \>4 and transaminases elevated more than 2 SD above upper limit of normal for age) 5. Liver malformations such as biliary atresia and choledochal cyst 6. Refusal of consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to full enteral feeding | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Growth | Through study completion, up to 1 year | Compare growth parameters (weight, length and head circumference) as daily g/kg/d and z-scores birth to discharge |
| Difference in conjugated bilirubin levels | 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. |
| Length of hospital stay | Through study completion, up to 6 months | The length of hospital stay described as the number of days spent in the hospital |
| Feeding interruptions | 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 |
| Number of days of parenteral nutrition | Through study completion, up to 1 year | The total number of days parenteral nutrition is required. |
| Episodes of Necrotizing Enterocolitis | 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 | 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 | 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). |
| Feeding intolerance | 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 |
Countries
United States
Outcome results
None listed