Necrotizing enterocolitis and exclusively human milk feeding through 33 weeks postmenstrual age

Plain English summary of protocol

Background and study aims
We are carrying out a study of premature infants born before 33 weeks gestation. Our goal is to determine whether a human milk diet works. Necrotizing enterocolitis (NEC) is a serious problem for the premature infant's small intestine. NEC occurs in 7 to 10% of infants with birth weights less than 1.5 kg. Premature infants typically receive cow’s milk-based products when the mother’s own milk (MOM) is not available. Elimination of cow's milk products from the premature infant’s diet, including cow's milk-based milk fortifiers, has been suggested as a possible way to reduce NEC.
We want to observe the rate of NEC in very premature infants when they receive a diet of exclusively human milk until they reach a minimum of 33 weeks postmenstrual age. The study’s findings should help to determine the rate of NEC associated with an entirely human milk diet.

Who can participate?
The study aims to recruit all premature infants born before 33 weeks gestation admitted to a single neonatal intensive care unit during a 30-month period.

What does the study involve?
Mothers of infants admitted to a neonatal intensive care unit (NICU) was encouraged to provide milk for their infants. Until infants were ready for milk feedings, they received nutrition intravenously. Milk production requires the mother to use electric pumps and hands on the breast to express their milk. Lactation consultants provide mothers with training and supplies. The MOM was refrigerated or frozen until it was used for feeding. In case they were unable to supply enough MOM, mothers were offered pasteurized donor human milk (DHM) from a milk bank as an alternative to cow’s milk formula. Mothers provided written consent in order to receive DHM. In the event that a fortifier of MOM or DHM was recommended, a DHM-based fortifier was provided. After 33 weeks, routine feeding practices permit artificial milk products when MOM was not available. At the end of the study we will evaluate the group for the appearance of NEC in relation to the diet provided.

What are the possible benefits and risks of participating?
The risk of NEC associated with an EHM diet is unknown; The EHM diet is the diet recommended by the American Academy of Pediatrics (AAP) for premature infants: MOM is the first choice, DHM is the second choice and formula is the last choice. DHM and DHM-based milk fortifier are expensive and they are nutritional products. Participating infants benefit from receipt of DHM products which are expensive and nutritional. The hospital pays for these products. The risk of using MOM includes infections or medications acquired by the infant from its mother’s milk. If necessary, DHM can be substituted for MOM, which is a potential benefit to the infant. The potential risk of the EHM diet leading to slower growth (compared to formula) which is balanced by providing DHM-based fortifier. The potential risks of a formula diet include an increased rate of NEC, excessive weight gain leading to obesity, and poorer developmental outcome at later ages. The balance of the multiple risks and benefits are not clear.

Where is the study run?
The study site is at the Deaconess-Women’s Hospital, located in Newburgh, IN, USA.

What is the study period?
July 2010 through December 2012.

Who is funding the study?
The Deaconess-Women’s Hospital.

Who is the main contact?
Dr Kenneth Herrmann
Kenneth.Herrmann@deaconess.com

Contact information

Study information

Eligibility

Locations

Countries of recruitment

• United States of America

Study participating centre

Sponsor information

Funders

Funder type

Hospital/treatment centre

Results and Publications

Study outputs