Effect of Early Feeding of Breast Milk
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|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
|Condition or disease||Intervention/treatment||Phase|
|Neonatal SEPSIS Weight Gain Feeding Disorder Neonatal||Other: preterm formula milk Other: exclusive breast milk||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|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|
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
- Weight gain [ Time Frame: 1 year ]
All newborn well examine regards weight
- Necrotizing enterocolitis.
- Neonatal Sepsis.
- Weight gain.
- Feeding tolerance
- Number of participants with complete blood pictures [ Time Frame: 1 year ]All newborn are examine