Effect of Early Feeding of Breast Milk

Not Applicable

• Conditions: Weight Gain; Feeding Disorder Neonatal; Neonatal SEPSIS
• Interventions: Other: preterm formula milk; Other: exclusive breast milk

• Registration Number: NCT03498989
• Lead Sponsor: 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.

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.

Study Timeline

• Status Verified: 2018-03
• Study First Submitted: 2018-03-21
• Study First Submitted QC: 2018-04-13
• Last Update Submitted: 2018-04-13
• Study First Posted: 2018-04-17
• Last Update Posted: 2018-04-17
• Study Start: 2018-06-21
• Primary Completion: 2019-03-21
• Study Completion: 2020-02-21

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
preterm formula milk neoborn	preterm formula milk	will be given preterm formula milk
exclusive breast milk	exclusive breast milk	will be given exclusive breast milk

Primary Outcome Measures

Name	Time	Method
Number of participants with complete blood pictures	1 year	All newborn are examine
Weight gain	1 year	All newborn well examine regards weight; 1. Necrotizing enterocolitis.; 2. Neonatal Sepsis.; 3. Weight gain.; 4. Feeding tolerance