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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
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Neonatal SEPSIS

Eligibility Criteria

1 Week - 1 Month (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Gestational age <37 weeks.
  2. Birth weight >1000 gm.

Exclusion Criteria:

  1. Gestational age 37 weeks.
  2. Birth weight < 1000 gm.
  3. Newborns with congenital anomalies.
  4. Newborns with suspected metabolic diseases.
  5. Newborns on mechanical ventilators.
  6. 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

    First Posted
    March 21, 2018
    Last Updated
    April 13, 2018
    Sponsor
    Assiut University
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    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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