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Clinical Trials/NCT03498989
NCT03498989
Unknown
Not Applicable

Effect of Early Feeding of Breast Milk Versus Formula Milk on Health Status of Preterm

Assiut University0 sites100 target enrollmentJune 21, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Neonatal SEPSIS
Sponsor
Assiut University
Enrollment
100
Primary Endpoint
Number of participants with complete blood pictures
Last Updated
8 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 21, 2018
End Date
February 21, 2020
Last Updated
8 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

AATaha

Paediatric

Assiut University

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.

Outcomes

Primary Outcomes

Number of participants with complete blood pictures

Time Frame: 1 year

All newborn are examine

Weight gain

Time Frame: 1 year

All newborn well examine regards weight 1. Necrotizing enterocolitis. 2. Neonatal Sepsis. 3. Weight gain. 4. Feeding tolerance

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