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Completed

NCT Number: NCT01731613

Adjustable Fortification of Human Milk Fed to Chinese Preterm Infants

This clinical trial will compare how the individualized and fortified human milk feeding will help a premature infant grow.

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Key information

Conditions

Infant, Premature, Diseases Congenital, Hereditary, and Neonatal Diseases and Abnormalities Infant, Newborn, Diseases

Age range

10 day–40 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

About this study

A total of 60 premature infants who will be randomized to receive either a standard fortification regimen (n=30) or an adjustable fortification regimen (n=30). The adjustable fortification regimen encompasses increasing / decreasing the amount of fortifier and adding supplemental protein guided by periodic determinations of the protein concentration in human milk (PCHM), body weight and blood urea nitrogen (BUN). Growth rate, tolerance of enteral feeding, days to achieve 100kcal/kg/d through enteral feeding, length of parenteral nutrition and NICU stays will be measured and compared between groups.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Less than 34 weeks gestational age at birth
  • Birth weight within 800-1800 grams
  • Exclusively or mostly breastfed (greater than 80% if the feeding volume)
  • Tolerated enteral feedings of 60 ml/kg/d
  • Remain in the Neonatal Intensive Care Unit at least 14 days prior to hospital discharge,remain in the Neonatal Intensive Care Unit at least 10 days after enrollment
  • Signed Informed Consent

Exclusion criteria

  • Small for gestational age
  • Infants currently receiving ventilation therapy
  • Major congenital malformations
  • Suspected or documented systemic or congenital infections
  • Evidence of cardiac, respiratory, endocrinologic, hematologic, gastrointestinal, or other systemic diseases that may impact growth
  • Severe intraventricular hemorrhage (greater than grade II) or periventricular leukomalacia
  • Suspected or documented maternal substance abuse
  • Infants currently receiving glucocorticoids or infants who have received glucocorticoids within the past 28 days

Treatment and study plan

Human Milk Fortifier

Dietary Supplement

Then fortification with human milk fortifier will be initiated at different levels according to the body weight of infants, the protein concentration of human milk and blood urea nitrogen

Other names: HMF

Primary outcomes

  1. Time to reach 100kcal/kg/d of enteral nutrition

    Time frame: participants will be followed until discharge, an expected average of 2 weeks

    Days to reach 100kcal/kg/d of enteral nutrition

  2. The weight gain velocity during hospitalization

    Time frame: participants will be followed until discharge, an expected average of 2 weeks

    The weight gain velocity(g/kg/d)

Secondary outcomes

  1. The protein and energy ratio of enteral nutrition each week after enrollment

    Time frame: participants will be followed until discharge, an expected average of 2 weeks

    The protein and energy ratio(g/100kcal)

  2. Time to reach 2000g of body weight

    Time frame: participants will be followed until discharge, an expected average of 2 weeks

    Days to reach 2000g of body weight

  3. metabolic indicators after enrollment, including BUN,prealbumin, albumin

    Time frame: participants will be followed until discharge, an expected average of 2 weeks

    BUN(mmol/L), prealbumin(mg/L), albumin(g/L)

Sponsors and collaborators

Lead sponsor

Peking Union Medical College Hospital

Other

Collaborators

  • Mead Johnson Nutrition

Registry information

Important dates

Study start
2012
Primary completion
2017
Study completion
2017
First posted
Nov 22, 2012
Registry last updated
Nov 28, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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