Human Milk for Congenital Gastrointestinal Disorders

Congenital Gastrointestinal Disorders Clinical Trial

— HM for CGD  

Official title:

Effects of an Exclusive Human Milk Diet on Enteral Feeding Outcomes of Neonates With Congenital Gastrointestinal Disorders

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02567292
• Other study ID #: IRB00080481
• Status: Completed
• Phase: N/A
• Start date: July 26, 2018
• Est. completion date: January 18, 2022

Study information

• Verified date: August 2023
• Source: Emory University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 151
• Est. completion date: January 18, 2022
• Est. primary completion date: January 18, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Minute to 1 Year

Eligibility

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

Related Conditions & MeSH terms

• Congenital Gastrointestinal Disorders
• Digestive System Diseases
• Gastrointestinal Diseases

Intervention

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)

Locations

Country	Name	City	State
United States	Children's Healthcare of Atlanta-Egleston	Atlanta	Georgia

Sponsors (3)

Lead Sponsor	Collaborator
Emory University	Chatham Valley Foundation, Prolacta Bioscience

Country where clinical trial is conducted

United States, 

References & Publications (1)

Shinnick JK, Wang E, Hulbert C, McCracken C, Sarson GY, Piazza A, Karpen H, Durham MM. Effects of a Breast Milk Diet on Enteral Feeding Outcomes of Neonates with Gastrointestinal Disorders. Breastfeed Med. 2016 Aug;11(6):286-292. doi: 10.1089/bfm.2016.000 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to full enteral feeding	The number of days to achieve full enteral feeding after the initial human milk feeding	From birth to day of life full enteral feedings for 7 days is achieved (up to 30 days)
Secondary	Number of days of parenteral nutrition	The total number of days parenteral nutrition is required.	Through study completion, up to 1 year
Secondary	Growth	Compare growth parameters (weight, length and head circumference) as daily g/kg/d and z-scores birth to discharge	Through study completion, up to 1 year
Secondary	Difference in conjugated bilirubin levels	The difference in average bilirubin level will be compared between the non-human milk diet (retrospective control group) and the breast milk diet group.	From birth to day of life full enteral feedings for 7 days is achieved (up to 30 days)
Secondary	Length of hospital stay	The length of hospital stay described as the number of days spent in the hospital	Through study completion, up to 6 months
Secondary	Feeding interruptions	NPO for at least 24 hours. NPO due to elective surgeries or procedures will not be defined as feeding interruptions	From birth to day of life full enteral feedings for 7 days is achieved (up to 30 days)
Secondary	Feeding intolerance	Number of days when one or more feedings were held for clinical concerns	From birth to day of life full enteral feedings for 7 days is achieved (up to 30 days)
Secondary	Episodes of Necrotizing Enterocolitis	Number of episodes of Stage IIb NEC or greater	From birth to day of life full enteral feedings for 7 days is achieved (up to 30 days)
Secondary	Number of sepsis episodes	The number of sepsis episodes will be compared between the non-breast milk diet (retrospective control group) and the breast milk diet group.	From birth to day of life full enteral feedings for 7 days is achieved (up to 30 days)
Secondary	Death rate	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).	Through study completion, up to 1 year