Effect of Early Feeding of Breast Milk

Weight Gain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03498989
• Other study ID #: Effect of early feeding
• Status: Not yet recruiting
• Phase: N/A
• First received: March 21, 2018
• Last updated: April 13, 2018
• Start date: June 21, 2018
• Est. completion date: February 21, 2020

Study information

• Verified date: March 2018
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: February 21, 2020
• Est. primary completion date: March 21, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 1 Month

Eligibility

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.

Related Conditions & MeSH terms

• Feeding and Eating Disorders
• Feeding Disorder Neonatal
• Neonatal SEPSIS
• Weight Gain

Intervention

Other:
• preterm formula milk
A. complete blood picture B. C-reactive protein C. Serum electrolytes D. Plain x-ray and abdominal ultrasound.
• exclusive breast milk
exclusive breast milk

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

References & Publications (2)

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. Erratum in: Am J Phys Anthropol. 2013 Dec;152(4):571. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Weight gain	All newborn well examine regards weight; Necrotizing enterocolitis.; Neonatal Sepsis.; Weight gain.; Feeding tolerance	1 year
Primary	Number of participants with complete blood pictures	All newborn are examine	1 year