Effect of Early Feeding of Breast Milk
1 other identifier
interventional
100
0 countries
N/A
Brief Summary
Breast milk is an extremely complex and highly variable biofliud that has evolved to nourish infants and protect them from disease whilst their own immune system matures. The composition of human breast milk changes in response to many factors, matching the infants requirement according to its age and other characteristics.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jun 2018
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 21, 2018
CompletedFirst Posted
Study publicly available on registry
April 17, 2018
CompletedStudy Start
First participant enrolled
June 21, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 21, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
February 21, 2020
CompletedApril 17, 2018
March 1, 2018
9 months
March 21, 2018
April 13, 2018
Conditions
Outcome Measures
Primary Outcomes (2)
Weight gain
All newborn well examine regards weight 1. Necrotizing enterocolitis. 2. Neonatal Sepsis. 3. Weight gain. 4. Feeding tolerance
1 year
Number of participants with complete blood pictures
All newborn are examine
1 year
Study Arms (2)
preterm formula milk neoborn
EXPERIMENTALwill be given preterm formula milk
exclusive breast milk
EXPERIMENTALwill be given exclusive breast milk
Interventions
A. complete blood picture B. C-reactive protein C. Serum electrolytes D. Plain x-ray and abdominal ultrasound.
Eligibility Criteria
You may qualify if:
- Gestational age \<37 weeks.
- Birth weight \>1000 gm.
You may not qualify if:
- Gestational age 37 weeks.
- Birth weight \< 1000 gm.
- Newborns with congenital anomalies.
- Newborns with suspected metabolic diseases.
- Newborns on mechanical ventilators.
- Newborns with suspected neonatal sepsis.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (2)
Fujita M, Roth E, Lo YJ, Hurst C, Vollner J, Kendell A. In poor families, mothers' milk is richer for daughters than sons: a test of Trivers-Willard hypothesis in agropastoral settlements in Northern Kenya. Am J Phys Anthropol. 2012 Sep;149(1):52-9. doi: 10.1002/ajpa.22092. Epub 2012 May 24.
PMID: 22623326BACKGROUNDMolinari CE, Casadio YS, Hartmann BT, Livk A, Bringans S, Arthur PG, Hartmann PE. Proteome mapping of human skim milk proteins in term and preterm milk. J Proteome Res. 2012 Mar 2;11(3):1696-714. doi: 10.1021/pr2008797. Epub 2012 Feb 22.
PMID: 22309230BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Paediatric
Study Record Dates
First Submitted
March 21, 2018
First Posted
April 17, 2018
Study Start
June 21, 2018
Primary Completion
March 21, 2019
Study Completion
February 21, 2020
Last Updated
April 17, 2018
Record last verified: 2018-03