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Adjustable Fortification of Human Milk Fed to Chinese Preterm Infants

Primary Purpose

Infant, Premature, Diseases

Status

Completed

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

human milk fortifier

About this trial

This is an interventional treatment trial for Infant, Premature, Diseases

Eligibility Criteria

10 Days - 40 Days (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Peking Union Medical College Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Standard Fortification

Adjustable fortification

Arm Description

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

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)

Outcomes

Primary Outcome Measures

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

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

The weight gain velocity during hospitalization

The weight gain velocity(g/kg/d)

Secondary Outcome Measures

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

The protein and energy ratio(g/100kcal)

Time to reach 2000g of body weight

Days to reach 2000g of body weight

metabolic indicators after enrollment, including BUN,prealbumin, albumin

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

Full Information

NCT ID

NCT01731613

First Posted

November 5, 2012

Last Updated

November 25, 2017

Sponsor

Peking Union Medical College Hospital

Collaborators

Mead Johnson Nutrition

1. Study Identification

Unique Protocol Identification Number

NCT01731613

Brief Title

Adjustable Fortification of Human Milk Fed to Chinese Preterm Infants

Official Title

Adjustable Fortification of Human Milk Fed to Chinese Preterm Infants

Study Type

Interventional

2. Study Status

Record Verification Date

November 2017

Overall Recruitment Status

Completed

Study Start Date

August 2012 (Actual)

Primary Completion Date

August 2017 (Actual)

Study Completion Date

August 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Peking Union Medical College Hospital

Collaborators

Mead Johnson Nutrition

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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

Detailed Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Infant, Premature, Diseases

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare Provider

Allocation

Randomized

Enrollment

51 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Standard Fortification

Arm Type

Active Comparator

Arm Description

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

Arm Title

Adjustable fortification

Arm Type

Experimental

Arm Description

Intervention Type

Dietary Supplement

Intervention Name(s)

human milk fortifier

Other Intervention Name(s)

HMF

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Description

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

Time Frame

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

Title

The weight gain velocity during hospitalization

Description

The weight gain velocity(g/kg/d)

Time Frame

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

Secondary Outcome Measure Information:

Title

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

Description

The protein and energy ratio(g/100kcal)

Time Frame

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

Title

Time to reach 2000g of body weight

Description

Days to reach 2000g of body weight

Time Frame

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

Title

metabolic indicators after enrollment, including BUN,prealbumin, albumin

Description

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

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

10 Days

Maximum Age & Unit of Time

40 Days

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Danhua Wang, Professor

Organizational Affiliation

Peking Union Medical College Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Peking Union Medical College Hospital

City

Beijing

State/Province

Beijing

ZIP/Postal Code

100730

Country

China

12. IPD Sharing Statement

Plan to Share IPD

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Adjustable Fortification of Human Milk Fed to Chinese Preterm Infants

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