Effect of Early Feeding of Breast Milk
Primary Purpose
Neonatal SEPSIS, Weight Gain, Feeding Disorder Neonatal
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
preterm formula milk
exclusive breast milk
Sponsored by
About this trial
This is an interventional prevention trial for Neonatal SEPSIS
Eligibility Criteria
Inclusion Criteria:
- Gestational age <37 weeks.
- Birth weight >1000 gm.
Exclusion Criteria:
- 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
preterm formula milk neoborn
exclusive breast milk
Arm Description
will be given preterm formula milk
will be given exclusive breast milk
Outcomes
Primary Outcome Measures
Weight gain
All newborn well examine regards weight
Necrotizing enterocolitis.
Neonatal Sepsis.
Weight gain.
Feeding tolerance
Number of participants with complete blood pictures
All newborn are examine
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03498989
Brief Title
Effect of Early Feeding of Breast Milk
Official Title
Effect of Early Feeding of Breast Milk Versus Formula Milk on Health Status of Preterm
Study Type
Interventional
2. Study Status
Record Verification Date
March 2018
Overall Recruitment Status
Unknown status
Study Start Date
June 21, 2018 (Anticipated)
Primary Completion Date
March 21, 2019 (Anticipated)
Study Completion Date
February 21, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
Detailed Description
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.
Therefore, the composition of breast milk is widely believed to be specifically tailored by each mother to precisely reflect the requirements of her infant.
Human milk is uniquely suited to the human infant, both in its nutritional composition and in the non-nutritive bioactive factors that promote survival and healthy development.
Breast milk contains over 400 different proteins which perform a variety of functions; providing nutrition, possessing antimicrobial and immunomodulatory activities, as well as stimulating the absorption of nutrients.
The immune system of preterm infants is immature, placing them at increased risk for serious immune-related complications.
Human milk provides a variety of immune protective and immune maturation factors that are beneficial to the preterm infants poorly developed immune system. The most studied immune components in human milk include antimicrobial proteins, maternal leukocytes, immunoglobulins, cytokines and chemokines, oligosaccharides, gangliosides, nucleotides, and long-chain polyunsaturated fatty acids. There is growing evidence that these components contribute to the lower incidence of immune-related conditions in the preterm infant. Therefore, provision of these components in human milk, donor milk, or formula may provide immunologic benefits.
The effects of breast milk and breastfeeding on neurodevelopment may be quite different in very preterm infants than in those born at full term. Nutritionally, breast milk is considered the optimal food for full term infants. But preterm infants require fortification to match third trimester nutrient accretion rates.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neonatal SEPSIS, Weight Gain, Feeding Disorder Neonatal
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
preterm formula milk neoborn
Arm Type
Experimental
Arm Description
will be given preterm formula milk
Arm Title
exclusive breast milk
Arm Type
Experimental
Arm Description
will be given exclusive breast milk
Intervention Type
Other
Intervention Name(s)
preterm formula milk
Intervention Description
A. complete blood picture
B. C-reactive protein
C. Serum electrolytes
D. Plain x-ray and abdominal ultrasound.
Intervention Type
Other
Intervention Name(s)
exclusive breast milk
Intervention Description
exclusive breast milk
Primary Outcome Measure Information:
Title
Weight gain
Description
All newborn well examine regards weight
Necrotizing enterocolitis.
Neonatal Sepsis.
Weight gain.
Feeding tolerance
Time Frame
1 year
Title
Number of participants with complete blood pictures
Description
All newborn are examine
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Week
Maximum Age & Unit of Time
1 Month
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Gestational age <37 weeks.
Birth weight >1000 gm.
Exclusion Criteria:
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.
12. IPD Sharing Statement
Citations:
PubMed Identifier
22623326
Citation
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. Erratum In: Am J Phys Anthropol. 2013 Dec;152(4):571.
Results Reference
background
PubMed Identifier
22309230
Citation
Molinari 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.
Results Reference
background
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Effect of Early Feeding of Breast Milk
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