Effect of Early Feeding of Breast Milk

NCT ID: NCT03498989

Last Updated: 2018-04-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-06-21

Study Completion Date

2020-02-21

Brief Summary

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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

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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.

Conditions

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Neonatal SEPSIS Weight Gain Feeding Disorder Neonatal

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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preterm formula milk neoborn

will be given preterm formula milk

Group Type EXPERIMENTAL

preterm formula milk

Intervention Type OTHER

A. complete blood picture

B. C-reactive protein

C. Serum electrolytes

D. Plain x-ray and abdominal ultrasound.

exclusive breast milk

will be given exclusive breast milk

Group Type EXPERIMENTAL

exclusive breast milk

Intervention Type OTHER

exclusive breast milk

Interventions

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preterm formula milk

A. complete blood picture

B. C-reactive protein

C. Serum electrolytes

D. Plain x-ray and abdominal ultrasound.

Intervention Type OTHER

exclusive breast milk

exclusive breast milk

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

1 Week

Maximum Eligible Age

1 Month

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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AATaha

Paediatric

Responsibility Role PRINCIPAL_INVESTIGATOR

References

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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.

Reference Type BACKGROUND
PMID: 22623326 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22309230 (View on PubMed)

Other Identifiers

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Effect of early feeding

Identifier Type: -

Identifier Source: org_study_id

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