Preterm Infant Multicentre Growth Study

Completed

• Conditions: Preterm Infant
• Interventions: Other: Growth

• Registration Number: NCT03064022
• Lead Sponsor: University of Calgary

Brief Summary

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.

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2009-02
• Study First Submitted: 2017-02-21
• Study First Submitted QC: 2017-02-23
• Study First Posted: 2017-02-24
• Primary Completion: 2018-12
• Status Verified: 2019-04
• Study Completion: 2019-06
• Last Update Submitted: 2020-04-23
• Last Update Posted: 2020-04-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1275

Inclusion Criteria

• < 32 weeks gestational age at birth

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Exclusion Criteria

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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Size < the 3rd or 10th percentiles	Growth	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

Primary Outcome Measures

Name	Time	Method
Neurodevelopment	Twenty-one months of age	Neurodevelopment (Bayley scale scores II and III), diagnoses of cerebral palsy, or other neurologic impairments) measured

Secondary Outcome Measures

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

Trial Locations

Locations (2)

Cumming School of Medicine; 🇨🇦 Calgary, Alberta, Canada

Regina Qu'Appelle Health Region; 🇨🇦 Regina, Saskatchewan, Canada