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Dietary Supplement

Analysis with Miris (AB) Human Milk Analyzer for Premature Birth

Q: What qualifications are necessary for individuals to be included in this experiment?

To qualify for this trial, infants must present with malnutrition and be under 21 days old. 50 participants are required to complete the study's requirements.

Q: Are there age restrictions for enrolling in this trial?

According to the rules of this particular trial, eligible participants must range in age from 1 day old up to 21 days.

Q: What is the aggregate headcount for participants in this research trial?

Affirmative. According to information published on clinicaltrials.gov, this medical trial has been actively searching for participants since March 9th 2020 and was last updated on September 16th 2022. They are seeking 50 patients from one particular site.

Q: Are participants currently being sought out for this scientific experiment?

Affirmative. Clinicaltrials.gov reveals that the medical trial, which was first published in March of 2020, is still recruiting participants. The researchers are aiming to recruit a total of 50 individuals from one site.

Q: What is the main purpose behind this clinical research endeavor?

This 11-week trial seeks to measure changes in length as its primary end point. Secondary objectives are the counting of feeding intolerance events, percentage of donor and mother's milk fed during the study period, and number of necrotizing enterocolitis episodes that occur.

N/A

Recruiting

Led By Marianne Garland, MD

Research Sponsored by Columbia University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Premature infants born </= 30 weeks gestational age

Birth Weight </= 1500 grams

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 1 year of age

Awards & highlights

Study Summary

This trial is comparing two ways of fortifying donor breast milk for preterm infants. The hypothesis is that targeted fortification will lead to better growth for infants.

Who is the study for?

This trial is for premature infants born at or before 30 weeks and weighing less than or equal to 1500 grams. It's not for those who are very small for their gestational age, have certain heart or gastrointestinal conditions, severe brain hemorrhage, haven't started fortified feeds by 3 weeks old, have necrotizing enterocolitis, or early onset sepsis.Check my eligibility

What is being tested?

The study tests if adding extra nutrients (targeted fortification) to donor breast milk helps preterm babies grow better compared to standard nutrient addition. Babies will be randomly assigned to receive either the standard or targeted fortification.See study design

What are the potential side effects?

Potential side effects may include digestive issues due to intolerance of the added nutrients in the fortified milk. However, specific side effects are not listed as this trial focuses on growth outcomes.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My baby was born at or before 30 weeks of pregnancy.

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My birth weight was 1500 grams or less.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in length

Change in weight

Head circumference

Secondary outcome measures

Incidence of Bronchopulmonary dysplasia

Incidence of Retinopathy of prematurity

Number of Feeding Intolerance Events

+4 more

Trial Design

2Treatment groups

Experimental Treatment

Group I: ExperimentalExperimental Treatment5 Interventions

Targeted fortification of breast milk

Group II: ControlExperimental Treatment5 Interventions

Standard fortification of breast milk

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Columbia UniversityLead Sponsor

1,436 Previous Clinical Trials

2,448,230 Total Patients Enrolled

19 Trials studying Premature Birth

8,738 Patients Enrolled for Premature Birth

Marianne Garland, MDPrincipal InvestigatorColumbia University

1 Previous Clinical Trials

32 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What qualifications are necessary for individuals to be included in this experiment?

"To qualify for this trial, infants must present with malnutrition and be under 21 days old. 50 participants are required to complete the study's requirements."

Answered by AI

Are there age restrictions for enrolling in this trial?

"According to the rules of this particular trial, eligible participants must range in age from 1 day old up to 21 days."

Answered by AI

What is the aggregate headcount for participants in this research trial?

"Affirmative. According to information published on clinicaltrials.gov, this medical trial has been actively searching for participants since March 9th 2020 and was last updated on September 16th 2022. They are seeking 50 patients from one particular site."

Answered by AI

Are participants currently being sought out for this scientific experiment?

"Affirmative. Clinicaltrials.gov reveals that the medical trial, which was first published in March of 2020, is still recruiting participants. The researchers are aiming to recruit a total of 50 individuals from one site."

Answered by AI

What is the main purpose behind this clinical research endeavor?

"This 11-week trial seeks to measure changes in length as its primary end point. Secondary objectives are the counting of feeding intolerance events, percentage of donor and mother's milk fed during the study period, and number of necrotizing enterocolitis episodes that occur."

Answered by AI

Recent research and studies

Journal of Human LactationJournal

Calibration Adjustment of the Mid-infrared Analyzer for an Accurate Determination of the Macronutrient Composition of Human Milk

Billard, Hélène, Laure Simon, Emmanuelle Desnots, Agnès Sochard, Cécile Boscher, Alain Riaublanc, Marie-Cécile Alexandre-Gouabau, and Clair-Yves Boquien. 2015. “Calibration Adjustment of the Mid-infrared Analyzer for an Accurate Determination of the Macronutrient Composition of Human Milk”. Journal of Human Lactation. SAGE Publications. doi:10.1177/0890334415588513.

Nutrition in Clinical PracticeJournal

Individualized Human Milk Fortification to Improve the Growth of Hospitalized Preterm Infants

Quan, Meiying, Danhua Wang, Lijuan Gou, Zhixing Sun, Jingran Ma, Lejia Zhang, Chen Wang, Kurt Schibler, and Zhenghong Li. 2019. “Individualized Human Milk Fortification to Improve the Growth of Hospitalized Preterm Infants”. Nutrition in Clinical Practice. Wiley. doi:10.1002/ncp.10366.

Clinical NutritionJournal

Rapid Measurement of Macronutrients in Breast Milk: How Reliable Are Infrared Milk Analyzers?

Fusch, Gerhard, Niels Rochow, Arum Choi, Stephanie Fusch, Susanna Poeschl, Adelaide Obianuju Ubah, Sau-Young Lee, Preeya Raja, and Christoph Fusch. 2015. “Rapid Measurement of Macronutrients in Breast Milk: How Reliable Are Infrared Milk Analyzers?”. Clinical Nutrition. Elsevier BV. doi:10.1016/j.clnu.2014.05.005.

PediatricsJournal