- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07818681
Predictors of Postnatal Growth Failure in Preterm Infants
Clinical and Nutritional Predictors of Postnatal Growth Failure in Preterm Infants Admitted to the Neonatal Intensive Care Unit of Assiut University Children's Hospital
Study Overview
Status
Detailed Description
Postnatal growth failure is a common complication among preterm infants admitted to neonatal intensive care units. This prospective cohort study will include preterm infants (gestational age less than 37 weeks) admitted to the NICU within the first 24 hours of life and hospitalized for at least 14 days.
Clinical data, nutritional practices, and serial anthropometric measurements will be collected from admission until hospital discharge. Postnatal growth failure will be defined as a discharge weight below the 10th percentile for postmenstrual age according to the Fenton Growth Chart and/or a decline in weight Z-score of more than 1.0 standard deviation between birth and discharge. The study will identify independent clinical and nutritional predictors of postnatal growth failure.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Kamal G Ahmed, Resident
- Phone Number: +20 11 41620746
- Email: kamal.18313193@med.aun.edu.eg
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- - Gestational age less than 37 completed weeks
- Admission to the NICU within the first 24 hours after birth
- Hospitalization for at least 14 days
- Availability of complete clinical, nutritional, and anthropometric data
- Written informed consent from parents or legal guardians
Exclusion Criteria:
- - Major congenital malformations
- Chromosomal abnormalities
- Major congenital gastrointestinal anomalies interfering with feeding
- Major congenital heart diseases requiring early surgical intervention
- Inborn errors of metabolism
- Congenital TORCH infections
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
|
Single cohort: Preterm infants admitted to NICU
Preterm infants with gestational age less than 37 weeks admitted to the NICU within 24 hours of birth and hospitalized for at least 14 days, followed until hospital discharge for assessment of postnatal growth failure and its predictors.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Occurrence of postnatal growth failure
Time Frame: Up to 30 days
|
Proportion of preterm infants who develop postnatal growth failure at hospital discharge, defined as discharge weight below the 10th percentile for postmenstrual age according to the Fenton Growth Chart, or a decline in weight-for-age Z-score of more than 1.0 standard deviation between birth and discharge.
|
Up to 30 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Growth velocity
Time Frame: Up to 30 days
|
Growth velocity expressed as grams per kilogram per day (g/kg/day) during hospitalization
|
Up to 30 days
|
|
Time to achieve full enteral feeding
Time Frame: Up to 30 days
|
Number of days from birth to achievement of full enteral feeding (150 mL/kg/day).
|
Up to 30 days
|
|
Duration of parenteral nutrition
Time Frame: Up to 30 days
|
Number of days of parenteral nutrition during hospitalization.
|
Up to 30 days
|
|
Length of hospital stay
Time Frame: Up to 30 days
|
Duration of hospitalization in days.
|
Up to 30 days
|
|
In-hospital mortality
Time Frame: Up to 30 days
|
Rate of mortality during the NICU stay.
|
Up to 30 days
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Kotb A Metwalley, prof, pediatrics Department, Assiut University Hospitals
Publications and helpful links
General Publications
- Guffey K, Regier M, Mancinelli C, Pergami P. Gait parameters associated with balance in healthy 2- to 4-year-old children. Gait Posture. 2016 Jan;43:165-9. doi: 10.1016/j.gaitpost.2015.09.017. Epub 2015 Sep 30.
- Embleton ND, Jennifer Moltu S, Lapillonne A, van den Akker CHP, Carnielli V, Fusch C, Gerasimidis K, van Goudoever JB, Haiden N, Iacobelli S, Johnson MJ, Meyer S, Mihatsch W, de Pipaon MS, Rigo J, Zachariassen G, Bronsky J, Indrio F, Koglmeier J, de Koning B, Norsa L, Verduci E, Domellof M. Enteral Nutrition in Preterm Infants (2022): A Position Paper From the ESPGHAN Committee on Nutrition and Invited Experts. J Pediatr Gastroenterol Nutr. 2023 Feb 1;76(2):248-268. doi: 10.1097/MPG.0000000000003642. Epub 2022 Oct 28.
- Fenton TR, Elmrayed S, Alshaikh BN. Fenton Third-Generation Growth Charts of Preterm Infants Without Abnormal Fetal Growth: A Systematic Review and Meta-Analysis. Paediatr Perinat Epidemiol. 2025 Aug;39(6):543-555. doi: 10.1111/ppe.70035. Epub 2025 Jun 19.
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- PGF-Preterm-NICU-Assiut-2026
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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