NCT01731613

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
51

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2012

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

November 5, 2012

Completed
17 days until next milestone

First Posted

Study publicly available on registry

November 22, 2012

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2017

Completed
Last Updated

November 28, 2017

Status Verified

November 1, 2017

Enrollment Period

5 years

First QC Date

November 5, 2012

Last Update Submit

November 25, 2017

Conditions

Infant, Premature, Diseases

Outcome Measures

Primary Outcomes (2)

  • Time to reach 100kcal/kg/d of enteral nutrition

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

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

  • The weight gain velocity during hospitalization

    The weight gain velocity(g/kg/d)

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

Secondary Outcomes (3)

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

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

  • Time to reach 2000g of body weight

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

  • metabolic indicators after enrollment, including BUN,prealbumin, albumin

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

Study Arms (2)

Standard Fortification

ACTIVE COMPARATOR

receive human milk fortified with human milk fortifier(HMF) in the standard amount (4 packs /100 ml of HM) throughout the study

Dietary Supplement: human milk fortifier

Adjustable fortification

EXPERIMENTAL

encompasses increasing/decreasing the amount of human milk fortifier(HMF) and adding supplemental protein guided by periodic determinations of the protein concentration of human milk (PCHM), body weight, blood urea nitrogen(BUN)

Dietary Supplement: human milk fortifier

Interventions

human milk fortifierDIETARY_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

Also known as: HMF
Adjustable fortificationStandard Fortification

Eligibility Criteria

Age10 Days - 40 Days
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

Location

MeSH Terms

Conditions

Infant, Premature, Diseases

Condition Hierarchy (Ancestors)

Infant, Newborn, DiseasesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Danhua Wang, Professor

    Peking Union Medical College Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

November 5, 2012

First Posted

November 22, 2012

Study Start

August 1, 2012

Primary Completion

August 1, 2017

Study Completion

August 1, 2017

Last Updated

November 28, 2017

Record last verified: 2017-11

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)