Skip to content

Effect of Early Feeding of Breast Milk

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03498989
Enrollment
100
Registered
2018-04-17
Start date
2018-06-21
Completion date
2020-02-21
Last updated
2018-04-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Feeding Disorder Neonatal, Neonatal SEPSIS, Weight Gain

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.

Interventions

OTHERpreterm formula milk

A. complete blood picture B. C-reactive protein C. Serum electrolytes D. Plain x-ray and abdominal ultrasound.

OTHERexclusive breast milk

exclusive breast milk

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
1 Weeks to 1 Months
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Weight gain1 yearAll newborn well examine regards weight 1. Necrotizing enterocolitis. 2. Neonatal Sepsis. 3. Weight gain. 4. Feeding tolerance
Number of participants with complete blood pictures1 yearAll newborn are examine

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026