Clinical trial NCT03064022: Preterm Infant Multicentre Growth Study
Official title: Preterm Infant Multicentre Growth Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Preterm Infant
Keywords: weight gain
head circumference
length
neurodevelopment
overweight
Lead sponsor: University of Calgary
Sponsor class: OTHER
Collaborators: name: Canadian Foundation for Dietetic Research (CFDR)
name: Saskatchewan Health Authority - Regina Area
name: Tufts University
First posted: 2017-02-24
Enrollment: 1275
Sex: ALL
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Preterm infants

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.

Eligibility criteria: Inclusion Criteria:

* \< 32 weeks gestational age at birth

Exclusion Criteria:

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

Primary outcomes:
measure: Neurodevelopment
timeFrame: Twenty-one months of age
Secondary outcomes:
measure: Overweight
timeFrame: Three years of age
measure: Growth patterns
timeFrame: From birth to 50 weeks post-menstrual age
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: Cumming School of Medicine
state: Alberta
city: Regina
country: Canada
facility: Regina Qu'Appelle Health Region
state: Saskatchewan
Study officials:
affiliation: University of Calgary
name: Tanis Fenton, PhD RD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
citation: 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.
citation: 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.