Preterm InfantPreMGSNCT03064022
Preterm Infant Multicentre Growth Study
An observational study of Preterm Infant, run by University of Calgary at 2 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 3 years
- Conditions the study is for
- Preterm Infant
- What is being tested?
- Growth
- How many people
- 1,275 participants
- Where
- 2 sitesCanada
- Study dates
- Feb 2009to Jun 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 3 years
- All sexes
- No healthy volunteers
- Child
Study population: Preterm infants
Who may be able to join
- < 32 weeks gestational age at birth
Who cannot join
- infants who had congenital anomalies or those who died prior to discharge
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
Cumming School of Medicine
Calgary, Alberta, T2N 4Z6
Regina Qu'Appelle Health Region
Regina, Saskatchewan, S4P 0W5
About this 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.
Read the 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.
- Conditions
- Preterm Infant
- Being tested
- Growth
- Keywords
- weight gain, head circumference, length, neurodevelopment, overweight
- Medical subject headings
- Premature Birth, Weight Gain, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GrowthOther
Some preterm infants grow at higher rates than others
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neurodevelopment
Neurodevelopment (Bayley scale scores II and III), diagnoses of cerebral palsy, or other neurologic impairments) measured
Measured: Twenty-one months of age
Secondary outcomes (2)
Overweight
Overweight will be defined as body mass index
Measured: Three years of age
Growth patterns
Growth patterns of preterm infants relative to the Fenton growth chart
Measured: From birth to 50 weeks post-menstrual age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2017
- Study startFeb 2009
- Primary completionDec 2018
- Study completionJun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Preterm InfantStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,275 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Calgary
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Foundation for Dietetic Research (CFDR), Saskatchewan Health Authority - Regina Area, Tufts University
- Responsible party
- Sponsor
- Investigators
- Tanis Fenton, PhD RD, Principal investigator, University of Calgary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03064022
- Sponsor's protocol ID
- REB15-2594
- Acronym
- PreMGS
- Status last verified
- Apr 2019
- First submitted
- 21 Feb 2017
- Last updated
- 27 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 23758808Fenton 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.
PubMed 29997166Fenton 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.
PubMed 30705399Fenton 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.
PubMed 34404924
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preterm Infant Multicentre Growth Study
- ClinicalTrials.gov ID
- NCT03064022
- Acronym / sponsor ID
- PreMGS / REB15-2594
- Conditions
- Preterm Infant
- Keywords
- weight gain, head circumference, length, neurodevelopment, overweight
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,275 participants (actual)
- Lead sponsor
- University of CalgaryUniversity, hospital or other
- Collaborators
- Canadian Foundation for Dietetic Research (CFDR), Saskatchewan Health Authority - Regina Area, Tufts University
- Study start
- Feb 2009 (actual)
- Primary completion
- Dec 2018 (actual)
- Study completion
- Jun 2019 (actual)
- First posted
- 24 Feb 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Size < the 3rd or 10th percentiles | – | Other: GrowthInfant 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 |
| 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 |
Who may qualify
- Ages
- Up to 3 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Preterm infants
Key inclusion criteria (1 listed)
- < 32 weeks gestational age at birth
Key exclusion criteria (1 listed)
- infants who had congenital anomalies or those who died prior to discharge
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GrowthSome preterm infants grow at higher rates than others | Other | Size < the 3rd or 10th percentiles |
Primary outcome
Neurodevelopment
Time frame: Twenty-one months of age
Neurodevelopment (Bayley scale scores II and III), diagnoses of cerebral palsy, or other neurologic impairments) measured
2 secondary outcomes
Overweight
Time frame: Three years of age
Growth patterns
Time frame: From birth to 50 weeks post-menstrual age
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2020.
- Results publication: PubMed 23758808Fenton 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.
- Results publication: PubMed 29997166Fenton 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.
- Results publication: PubMed 30705399Fenton 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.
- Derived from this study: PubMed 34404924Fenton 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.
- Fenton preterm growth chart webpageLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tanis Fenton, PhD RD principal investigator
University of Calgary
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Preterm Infant, run by University of Calgary at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neurodevelopment (time frame: Twenty-one months of age). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03064022, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2020.