Preterm Infant Multicentre Growth Study

Preterm Infant Clinical Trial

— PreMGS  

Official title:

Preterm Infant Multicentre Growth Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03064022
• Other study ID #: REB15-2594
• Status: Completed
• Start date: February 2009
• Est. completion date: June 2019

Study information

• Verified date: April 2019
• Source: University of Calgary
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1275
• Est. completion date: June 2019
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 3 Years

Eligibility

Inclusion Criteria:

• < 32 weeks gestational age at birth

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Premature Birth
• Preterm Infant

Intervention

Other:
• Growth
Some preterm infants grow at higher rates than others

Locations

Country	Name	City	State
Canada	Cumming School of Medicine	Calgary	Alberta
Canada	Regina Qu'Appelle Health Region	Regina	Saskatchewan

Sponsors (4)

Lead Sponsor	Collaborator
University of Calgary	Canadian Foundation for Dietetic Research (CFDR), Saskatchewan Health Authority - Regina Area, Tufts University

Country where clinical trial is conducted

Canada, 

References & Publications (3)

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 — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Neurodevelopment	Neurodevelopment (Bayley scale scores II and III), diagnoses of cerebral palsy, or other neurologic impairments) measured	Twenty-one months of age
Secondary	Overweight	Overweight will be defined as body mass index	Three years of age
Secondary	Growth patterns	Growth patterns of preterm infants relative to the Fenton growth chart	From birth to 50 weeks post-menstrual age

External Links

•   Fenton preterm growth chart webpage