NCT03064022

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,275

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2009

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2009

Completed
8.1 years until next milestone

First Submitted

Initial submission to the registry

February 21, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 24, 2017

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2019

Completed
Last Updated

April 27, 2020

Status Verified

April 1, 2019

Enrollment Period

9.8 years

First QC Date

February 21, 2017

Last Update Submit

April 23, 2020

Conditions

Preterm Infant

Keywords

weight gainhead circumferencelengthneurodevelopmentoverweight

Outcome Measures

Primary Outcomes (1)

  • Neurodevelopment

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

    Twenty-one months of age

Secondary Outcomes (2)

  • Overweight

    Three years of age

  • Growth patterns

    From birth to 50 weeks post-menstrual age

Study Arms (4)

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

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

Interventions

GrowthOTHER

Some preterm infants grow at higher rates than others

Size < the 3rd or 10th percentiles

Eligibility Criteria

AgeUp to 3 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Preterm infants

You may qualify if:

  • \< 32 weeks gestational age at birth

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Cumming School of Medicine

Calgary, Alberta, T2N 4Z6, Canada

Location

Regina Qu'Appelle Health Region

Regina, Saskatchewan, S4P 0W5, Canada

Location

Related Publications (4)

  • Fenton TR, Nasser R, Eliasziw M, Kim JH, Bilan D, Sauve R. Validating the weight gain of preterm infants between the reference growth curve of the fetus and the term infant. BMC Pediatr. 2013 Jun 11;13:92. doi: 10.1186/1471-2431-13-92.

    PMID: 23758808RESULT

  • Fenton TR, Senterre T, Griffin IJ. Time interval for preterm infant weight gain velocity calculation precision. Arch Dis Child Fetal Neonatal Ed. 2019 Mar;104(2):F218-F219. doi: 10.1136/archdischild-2018-314843. Epub 2018 Jul 11.

    PMID: 29997166RESULT

  • Fenton TR, Griffin IJ, Hoyos A, Groh-Wargo S, Anderson D, Ehrenkranz RA, Senterre T. Accuracy of preterm infant weight gain velocity calculations vary depending on method used and infant age at time of measurement. Pediatr Res. 2019 Apr;85(5):650-654. doi: 10.1038/s41390-019-0313-z. Epub 2019 Jan 25.

    PMID: 30705399RESULT

  • Fenton TR, Nasser R, Creighton D, Elmrayed S, Tang S, Gillis C, Alshaikh B. Critical examination of relationships between early growth and childhood overweight in extremely preterm infants. J Perinatol. 2021 Dec;41(12):2774-2781. doi: 10.1038/s41372-021-01182-8. Epub 2021 Aug 17.

    PMID: 34404924DERIVED

Related Links

MeSH Terms

Conditions

Premature BirthWeight GainOverweight

Interventions

Growth

Condition Hierarchy (Ancestors)

Obstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesBody Weight ChangesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsOvernutritionNutrition DisordersNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Growth and DevelopmentPhysiological Phenomena

Study Officials

  • Tanis Fenton, PhD RD

    University of Calgary

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 21, 2017

First Posted

February 24, 2017

Study Start

February 1, 2009

Primary Completion

December 1, 2018

Study Completion

June 1, 2019

Last Updated

April 27, 2020

Record last verified: 2019-04

Data Sharing

IPD Sharing
Will not share

Locations

CA(2)