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Adjustable Fortification of Human Milk Fed to Chinese Preterm Infants

NCT ID: NCT01731613

Last Updated: 2017-11-28

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

COMPLETED

Clinical Phase

NA

Total Enrollment

51 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-08-31

Study Completion Date

2017-08-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Infant, Premature, Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Standard Fortification

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

Group Type ACTIVE_COMPARATOR

human milk fortifier

Intervention Type 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

Adjustable fortification

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)

Group Type EXPERIMENTAL

human milk fortifier

Intervention Type 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

Interventions

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human milk fortifier

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

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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HMF

Eligibility Criteria

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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
Minimum Eligible Age

10 Days

Maximum Eligible Age

40 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mead Johnson Nutrition

INDUSTRY

Sponsor Role collaborator

Peking Union Medical College Hospital

OTHER

Sponsor Role lead

Responsible Party

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Danhua Wang

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Danhua Wang, Professor

Role: PRINCIPAL_INVESTIGATOR

Peking Union Medical College Hospital

Locations

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Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

Site Status

Countries

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China

Other Identifiers

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8648

Identifier Type: -

Identifier Source: org_study_id