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

NCT03258957 | Completed

• 1 other identifier: CZZ-MILK
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Feasibility of fresh breast milk

  Feasibility as defined by the percentage of mothers who can provide at least 1 feed of fresh milk a day from study enrollment until the infants are 32 weeks CGA

  3 year

Secondary Outcomes (6)

• NEC

  3 year

• Mortality

  3 year

• sepsis

  3 year

• Growth

  3 year

• Retinopathy of prematurity

  3 year

Study Arms (1)

Fresh milk group

EXPERIMENTAL

In the intervention group, 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.

Other: Fresh Milk

Interventions

Fresh Milk OTHER

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

Fresh milk group

Eligibility Criteria

• Age: 1 Hour - 3 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may not qualify if:

• Infants with major congenital anomalies, receiving palliative care, or where illness of the mother or infant prevents the administration of breast milk feeds in the first week of the infant's life will be excluded from the trial

Sponsors & Collaborators

• Huiqing Sun: lead
• Nanjing Children's Hospital: collaborator
• Nanjing Maternity and Child Health Care Hospital: collaborator
• Shanghai First Maternity and Infant Hospital: collaborator
• The Third Xiangya Hospital of Central South University: collaborator
• Children's Hospital of Fudan University: collaborator
• Mount Sinai Hospital, Canada: collaborator

Study Sites (1)

Zhengzhou Children's Hospital

Zhengzhou, Henan, 450018, China

Location

Related Publications (1)

• Sun H, Han S, Cheng R, Hei M, Kakulas F, Lee SK. Testing the feasibility and safety of feeding preterm infants fresh mother's own milk in the NICU: A pilot study. Sci Rep. 2019 Jan 30;9(1):941. doi: 10.1038/s41598-018-37111-7.

  PMID: 30700726 DERIVED

MeSH Terms

Conditions

Enterocolitis, Necrotizing

Condition Hierarchy (Ancestors)

Enterocolitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Study Officials

• Shuying Luo, MD

  Zhengzhou Children's Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: The director of neonatal intensive care unit

Study Record Dates

• First Submitted: May 12, 2017
• First Posted: August 23, 2017
• Study Start: January 1, 2016
• Primary Completion: December 31, 2017
• Study Completion: December 31, 2017
• Last Updated: September 5, 2018

Record last verified: 2018-09

Locations

CN (1)