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Effect of Early Feeding of Breast Milk

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03498989
Recruitment Status : Unknown
Verified March 2018 by AATaha, Assiut University.
Recruitment status was:  Not yet recruiting
First Posted : April 17, 2018
Last Update Posted : April 17, 2018
Sponsor:
Information provided by (Responsible Party):
AATaha, Assiut University

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.

Condition or disease Intervention/treatment Phase
Neonatal SEPSIS Weight Gain Feeding Disorder Neonatal Other: preterm formula milk Other: exclusive breast milk Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: Effect of Early Feeding of Breast Milk Versus Formula Milk on Health Status of Preterm
Estimated Study Start Date : June 21, 2018
Estimated Primary Completion Date : March 21, 2019
Estimated Study Completion Date : February 21, 2020

Arm Intervention/treatment
Experimental: preterm formula milk neoborn
will be given preterm formula milk
Other: preterm formula milk

A. complete blood picture

B. C-reactive protein

C. Serum electrolytes

D. Plain x-ray and abdominal ultrasound.


Experimental: exclusive breast milk
will be given exclusive breast milk
Other: exclusive breast milk
exclusive breast milk




Primary Outcome Measures :
  1. Weight gain [ Time Frame: 1 year ]

    All newborn well examine regards weight

    1. Necrotizing enterocolitis.
    2. Neonatal Sepsis.
    3. Weight gain.
    4. Feeding tolerance

  2. Number of participants with complete blood pictures [ Time Frame: 1 year ]
    All newborn are examine



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Ages Eligible for Study:   up to 1 Month   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Publications:
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Responsible Party: AATaha, Paediatric, Assiut University
ClinicalTrials.gov Identifier: NCT03498989    
Other Study ID Numbers: Effect of early feeding
First Posted: April 17, 2018    Key Record Dates
Last Update Posted: April 17, 2018
Last Verified: March 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Neonatal Sepsis
Weight Gain
Feeding and Eating Disorders
Body Weight Changes
Body Weight
Signs and Symptoms
Sepsis
Infection
Infant, Newborn, Diseases
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Mental Disorders