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Completed

NCT Number: NCT03064022

Preterm Infant Multicentre Growth Study

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.

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Key information

Conditions

Preterm Infant Body Weight Body Weight Changes Female Urogenital Diseases and Pregnancy Complications Nutrition Disorders Nutritional and Metabolic Diseases Obstetric Labor Complications Obstetric Labor, Premature Overnutrition Overweight Pathological Conditions, Signs and Symptoms Pregnancy Complications Premature Birth Signs and Symptoms Urogenital Diseases Weight Gain

Age range

Up to 3 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Cumming School of Medicine, Calgary, Alberta, Canada

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • < 32 weeks gestational age at birth

Exclusion criteria

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

Treatment and study plan

Growth

Other

Some preterm infants grow at higher rates than others

Primary outcomes

  1. Neurodevelopment

    Time frame: Twenty-one months of age

    Neurodevelopment (Bayley scale scores II and III), diagnoses of cerebral palsy, or other neurologic impairments) measured

Secondary outcomes

  1. Overweight

    Time frame: Three years of age

    Overweight will be defined as body mass index

  2. Growth patterns

    Time frame: From birth to 50 weeks post-menstrual age

    Growth patterns of preterm infants relative to the Fenton growth chart

Sponsors and collaborators

Lead sponsor

University of Calgary

Other

Collaborators

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

Registry information

Acronym: PreMGS

Important dates

Study start
2009
Primary completion
2018
Study completion
2019
First posted
Feb 24, 2017
Registry last updated
Apr 27, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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