Targeted Fortification of Pasteurized Donor Human Milk

October 8, 2024 updated by: KK Women's and Children's Hospital

Targeted Fortification of Pasteurized Donor Human Milk to Improve Growth in Very Low Birth Weight Infants

This randomized controlled trial aims to evaluate a modified targeted fortification method of pasteurized donor human milk (PDHM) in very low birth weight infants (VLBWs). Pools of PDHM will be analyzed for macronutrient content using the Miris Human Milk Analyzer. The control arm will receive standard of care, which is PDHM without additional protein fortification. The intervention arm will receive PDHM with a fat content of 3.8g/dL or more, with additional protein fortification of 0.67g/dL. Primary outcome will be rate of malnutrition at hospital discharge or 37 weeks, whichever earlier. Secondary outcomes include body composition, feed tolerance, and morbidity outcomes.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Our hospital milk bank provides pasteurized donor human milk (PDHM) to very low birth weight (VLBW) infants without sufficient mother's milk, with the overall aim of lowering the risk of necrotizing enterocolitis in this population. However, with the introduction of PDHM in our setting, rates of suboptimal weight gain have increased (60.2% to 65.7%). This is likely due to the fact that PDHM is often lower in energy and protein than preterm mother's own milk. One solution to delivery adequate nutrition in this VLBWs receiving PDHM, is targeted fortification, which involves measurement of the macronutrient content of human milk, and adding extra macronutrients to reach nutrient goals. In this proposed study, we will conduct a pilot randomized controlled trial of a modified targeted fortification versus standard care. This study will include preterm VLBW infants (<1500g), without congenital conditions resulting in growth restriction, and receiving >25% of PDHM use in the first week of life. 40 patients in each arm will be recruited over a period of 2 years. The intervention group will receive a modified targeted fortification, consisting of selection of high fat PDHM (3.8g/dL or more) with the addition of protein fortification of 0.67g/dL from week 2 of life until a gestational age of 37 weeks or hospital discharge, whichever earlier. The control group will receive usual regular PDHM with standard fortification using human milk fortifier as per current practice. The primary outcome is the rate of suboptimal growth (drop in weight z-score from birth ≥0.8) at discharge or 37 weeks. Secondary outcomes include body composition, feed tolerance, and morbidity outcomes.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
61

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Singapore
      • Singapore, Singapore, 229899
        • KK Women's and Children's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

No older than 8 months (Child)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Birth weight less than or equal to 1500g
  • Born at our study hospital or transferred to study hospital within first week of life
  • Achieving at least 40ml/kg/day of enteral feeds by day 7 of life
  • Receiving at least 25% of pasteurized donor human milk within first 7 days of life

Exclusion Criteria:

  • Diagnosed or suspected inborn errors of metabolism
  • Acute or chronic renal impairment
  • Congenital disease associated with significant growth impairment (including, but not limited to, Trisomy 21, neonatal encephalopathy and seizures, neonatal tumours, achondroplasia, complex congenital heart disease, anorectal malformations, gastrointestinal disorders)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Intervention group (modified targeted fortification)
Pasteurized Donor Human Milk (PDHM) will be analyzed using the Miris Human Milk Analyzer, and PDHM with a fat content of 3.8g/dL or higher will be selected. Additional protein will be added using liquid protein fortifier (Similac) at 1ml to every 25ml PDHM to give an additional 0.67g/dL protein.
Dietary supplement: Protein supplementation
Liquid protein fortifier (Similac) will be added at 1ml per 25ml of PDHM at 130ml/kg/day of feed volume.
Other: Analysis with Miris Human Milk Analyzer
PDHM macronutrient content will be analyzed using the Miris Human Milk Analyzer and PDHM with fat content of 3.8g/dL or higher will be selected and provided.
No Intervention: Control group (standard fortification)
Pasteurized Donor Human Milk (PDHM) will be fortified as per unit protocols, at 1 packet of Human Milk Fortifier (Similac or Pre-Nan) to every 25ml PDHM at a feed volume of 80ml/kg/day

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Malnutrition rate
Time Frame: Hospital discharge or 37 weeks gestation, whichever earlier
Malnutrition is defined as a decline in weight z-score from birth of 0.8 or more
Hospital discharge or 37 weeks gestation, whichever earlier

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Linear growth
Time Frame: Hospital discharge or 37 weeks post menstrual age, whichever earlier
Linear growth will be assessed using z-score changes from birth
Hospital discharge or 37 weeks post menstrual age, whichever earlier
Body composition
Time Frame: Hospital discharge or 37 weeks gestation, whichever earlier
Percent fat mass and fat-free mass measured using air displacement plethysmography
Hospital discharge or 37 weeks gestation, whichever earlier
Head circumference growth
Time Frame: Hospital discharge or 37 weeks gestation, whichever earlier
Head circumference will be assessed using z-score changes from birth
Hospital discharge or 37 weeks gestation, whichever earlier
High calorie formula use
Time Frame: Hospital discharge or 35 weeks gestation, whichever earlier
Proportion of high calorie formula use (e.g. 27kcal/oz or 30kcal/oz formula)
Hospital discharge or 35 weeks gestation, whichever earlier
Bronchopulmonary dysplasia
Time Frame: Hospital discharge or 37 weeks gestation, whichever earlier
Proportion of patients with bronchopulmonary dysplasia
Hospital discharge or 37 weeks gestation, whichever earlier
Retinopathy of prematurity
Time Frame: Hospital discharge or 37 weeks gestation, whichever earlier
Proportion of patients with retinopathy of prematurity
Hospital discharge or 37 weeks gestation, whichever earlier

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Neurodevelopmental scores
Time Frame: 18 to 24 months post menstrual age
Bayley Scales of Infant and Toddler Development scale scores
18 to 24 months post menstrual age
Infant motor performance
Time Frame: Hospital discharge or 37 weeks gestation, whichever earlier
Test of Infant Motor Performance scores measured by trained physiotherapists
Hospital discharge or 37 weeks gestation, whichever earlier
Duration of hospital stay
Time Frame: Hospital discharge, assessed up to 180 days post menstrual age
Days of hospital stay, up to 180 days post menstrual age
Hospital discharge, assessed up to 180 days post menstrual age

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
KK Women's and Children's Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Chengsi Ong, KK Women's and Children's Hospital, Singapore

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 21, 2023

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 10, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 18, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 23, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 10, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 8, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2020/2493

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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