Pilot Study of the Feasibility of Feeding Preterm Infants With Fresh Versus Frozen Mother's Own Breast Milk in the NICU

Summary

Necrotizing enterocolitis (NEC) is a severe inflammatory disorder of the intestine that primarily affects very low birth weight (\<1,500 g)/very preterm infants (≤32 weeks' gestation); it is also the leading cause of death in the neonatal intensive care unit (NICU).Perhaps the best form of treatment for NEC is prevention. Mother's breast milk is best for preventing NEC. Breast milk contains both nutritional components (proteins, amino acids, fats, carbohydrates, vitamins, and minerals) and bioactive components (macrophages, T cells, cytokines, hormones, and growth factors) that have antimicrobial and anti-inflammatory properties.The current NICU breast milk feeding procedure exists as a means of ensuring that infants have consistent access to their mother's breast milk even if the mother is not able to spend time in the NICU. The process also allows for stricter quality and infection control, as well as computerised inventory and monitoring via electronic health records.However, the process deprives infants of the benefits of the cellular content of breast milk, including the stem cells.The primary objective of this study isto evaluate the feasibility and safety ofproviding very preterm infants (born at \<30 weeks' gestation) with fresh milk (within 4 hours of expression).While we acknowledge that as a pilot the study will not be powered to detect a statistically significant difference, our secondary objective is to identify if this approach has the potential to improve infant outcomes, particularly with regards to the occurrence of NEC.

Our hypothesis is that it is feasible for many mothers to provide at least 1 feed of fresh breast milk (\<4 hours post expression per day, and is not frozen, chilled or pasteurized) and that this may decrease the prevalence of NEC

Conditions

• Necrotizing Enterocolitis

Interventions

OTHER

Fresh Milk

Mothers will be asked to provide at least 1 feed of fresh milk (i.e. within 4 hours of milk expression) per day, other time, feed frozen milk

Sponsors & Collaborators

• Nanjing Children's Hospital

  collaborator OTHER

• Nanjing Maternity and Child Health Care Hospital

  collaborator OTHER

• Shanghai First Maternity and Infant Hospital

  collaborator OTHER

• The Third Xiangya Hospital of Central South University

  collaborator OTHER

• Children's Hospital of Fudan University

  collaborator OTHER

• Mount Sinai Hospital, Canada

  collaborator OTHER

• Huiqing Sun

  lead OTHER

Principal Investigators

• Shuying Luo, MD · Zhengzhou Children's Hospital

Study Design

Allocation

NA

Purpose

PREVENTION

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

1 Hour

Max Age

3 Days

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2016-01-01

Primary Completion

2017-12-31

Completion

2017-12-31

Countries

• China

Study Locations