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

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ClinicalTrials.gov Identifier: NCT03258957
Recruitment Status : Recruiting
First Posted : August 23, 2017
Last Update Posted : August 23, 2017
Sponsor:
Collaborators:
Nanjing Children's Hospital
Nanjing Maternity and Child Health Care Hospital
Shanghai First Maternity and Infant Hospital
The Third Xiangya Hospital of Central South University
Children's Hospital of Fudan University
Mount Sinai Hospital, Canada
Information provided by (Responsible Party):
Huiqing Sun, Zhengzhou Children's Hospital, China

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


Condition or disease Intervention/treatment Phase
Necrotizing Enterocolitis Other: Fresh Milk Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Pilot Study of the Feasibility of Feeding Preterm Infants With Fresh Versus Frozen Mother's Own Breast Milk in the NICU
Actual Study Start Date : January 1, 2016
Estimated Primary Completion Date : December 31, 2018
Estimated Study Completion Date : December 31, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Fresh milk group
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
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




Primary Outcome Measures :
  1. Feasibility of fresh breast milk [ Time Frame: 3 year ]
    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


Secondary Outcome Measures :
  1. NEC [ Time Frame: 3 year ]
    NEC more than stage 2 NEC stage 1 Need for surgery for NEC

  2. Mortality [ Time Frame: 3 year ]
    Compare the mortality between two groups

  3. sepsis [ Time Frame: 3 year ]
    Late-onset sepsis

  4. Growth [ Time Frame: 3 year ]
    Growth as measured by weight

  5. Retinopathy of prematurity [ Time Frame: 3 year ]
    Retinopathy of prematurity was screened and analysed

  6. Bronchopulmonary dysplasia [ Time Frame: 3 year ]
    Retinopathy of prematurity was defined and compared between two groups



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Ages Eligible for Study:   up to 3 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Eligible infants will include those born at <30 weeks gestation,and who have never received infant formula. For inclusion in the intervention group, the mother must bewilling to commit to providingat least 1 feed of fresh breast milk a day, 7 days a week

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03258957


Contacts
Contact: Huiqing Sun, PhD 13838112692 s_huiqing@sina.com
Contact: Shuying Luo, MD 13526559369 zzsetyykjk2015@163.com

Locations
China, Henan
Zhengzhou Children's Hospital Recruiting
Zhengzhou, Henan, China, 450018
Contact: Huiqing Sun, PhD    13838112692    s_huiqing@sina.com   
Contact: Shuying Luo, MD    13526559369    zzsetyykjk2015@163.com   
Sponsors and Collaborators
Huiqing Sun
Nanjing Children's Hospital
Nanjing Maternity and Child Health Care Hospital
Shanghai First Maternity and Infant Hospital
The Third Xiangya Hospital of Central South University
Children's Hospital of Fudan University
Mount Sinai Hospital, Canada
Investigators
Study Chair: Shuying Luo, MD Zhengzhou Children's Hospital

Responsible Party: Huiqing Sun, The director of neonatal intensive care unit, Zhengzhou Children's Hospital, China
ClinicalTrials.gov Identifier: NCT03258957     History of Changes
Other Study ID Numbers: CZZ-MILK
First Posted: August 23, 2017    Key Record Dates
Last Update Posted: August 23, 2017
Last Verified: August 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Enterocolitis
Enterocolitis, Necrotizing
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases