Preterm Infant Multicentre Growth Study (PreMGS)

April 23, 2020 updated by: University of Calgary
The purpose of this study is to improve health professionals understanding of preterm infant growth patterns, and to determine if early growth patterns predict risks of adverse metabolic and cognitive outcomes.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The purpose of this study is:

To improve health professionals understanding of preterm infant growth patterns, and to determine if growth patterns (rapid early growth in the first 2 weeks of life, weight less than the 10th percentile at the time of discharge) predict risks of adverse metabolic outcomes (measured as overweight at age 3) once the following variables are controlled for: size at birth (z-score), neonatal morbidities, social determinants of health, and nutritional adequacy in the neonatal intensive care unit (NICU).

To assess diagnostic accuracy of 36-week anthropometric weight, length and head circumference <10th and <3rd percentiles to predict preterm infant cognitive impairment.

Study Type

Observational

Enrollment (Actual)

1275

Contacts and Locations

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

Study Locations

  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 4Z6
        • Cumming School of Medicine
    • Saskatchewan
      • Regina, Saskatchewan, Canada, S4P 0W5
        • Regina Qu'Appelle Health Region

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

Ages Eligible for Study

No older than 3 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Preterm infants

Description

Inclusion Criteria:

  • < 32 weeks gestational age at birth

Exclusion Criteria:

  • infants who had congenital anomalies or those who died prior to discharge

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Size < the 3rd or 10th percentiles
Infant size smaller than the 3rd or 10th percentiles relative to the Fenton growth chart for weight or head circumference at discharge from neonatal intensive care
Other: Growth
Some preterm infants grow at higher rates than others
Rapid early growth
Rapid early growth will be defined as exceeding birthweight in the first week of life
Growth velocity calculation methods
We will compare a variety of growth velocity calculation methods used in clinical care and research to compare and assess growth velocity calculation methods
Size for gestational age
Small size for gestational age

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Neurodevelopment
Time Frame: Twenty-one months of age
Neurodevelopment (Bayley scale scores II and III), diagnoses of cerebral palsy, or other neurologic impairments) measured
Twenty-one months of age

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overweight
Time Frame: Three years of age
Overweight will be defined as body mass index
Three years of age
Growth patterns
Time Frame: From birth to 50 weeks post-menstrual age
Growth patterns of preterm infants relative to the Fenton growth chart
From birth to 50 weeks post-menstrual age

Collaborators and Investigators

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

Sponsor

University of Calgary

Collaborators

Tufts University
Saskatchewan Health Authority - Regina Area
Canadian Foundation for Dietetic Research (CFDR)

Investigators

  • Principal Investigator: Tanis Fenton, PhD RD, University of Calgary

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

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)

February 1, 2009

Primary Completion (Actual)

December 1, 2018

Study Completion (Actual)

June 1, 2019

Study Registration Dates

First Submitted

February 21, 2017

First Submitted That Met QC Criteria

February 23, 2017

First Posted (Actual)

February 24, 2017

Study Record Updates

Last Update Posted (Actual)

April 27, 2020

Last Update Submitted That Met QC Criteria

April 23, 2020

Last Verified

April 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REB15-2594

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

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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