NCT07818681

Brief Summary

This prospective observational study aims to identify the clinical and nutritional predictors of postnatal growth failure among preterm infants admitted to the Neonatal Intensive Care Unit of Assiut University Children's Hospital.

Trial Health

65
Monitor

Trial Health Score

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

Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
22mo left

Started Sep 2026

Status
not yet recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress2%
Sep 2026Jul 2028

First Submitted

Initial submission to the registry

September 2, 2026

Completed
12 days until next milestone

First Posted

Study publicly available on registry

September 14, 2026

Completed
6 days until next milestone

Study Start

First participant enrolled

September 20, 2026

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 25, 2027

Expected
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2028

Last Updated

September 14, 2026

Status Verified

September 1, 2026

Enrollment Period

1 year

First QC Date

September 2, 2026

Last Update Submit

September 10, 2026

Conditions

Growth FailurePremature BirthVery Low Birth Weight Infant

Keywords

Clinical predictorsPostnatal growth failurePreterm infantsNeonatal intensive careNutritional predictorsAssiut

Outcome Measures

Primary Outcomes (1)

  • Occurrence of postnatal growth failure

    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 Outcomes (5)

  • Growth velocity

    Up to 30 days

  • Time to achieve full enteral feeding

    Up to 30 days

  • Duration of parenteral nutrition

    Up to 30 days

  • Length of hospital stay

    Up to 30 days

  • In-hospital mortality

    Up to 30 days

Study Arms (1)

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.

Eligibility Criteria

AgeUp to 36 Weeks
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Preterm infants admitted to the Neonatal Intensive Care Unit of Assiut University Children's Hospital.

You may qualify if:

  • \- 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

You may not qualify if:

  • \- 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • 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.

    PMID: 36705703BACKGROUND

  • 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.

    PMID: 40534585BACKGROUND

  • 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.

    PMID: 26439183BACKGROUND

MeSH Terms

Conditions

Premature BirthFailure to Thrive

Condition Hierarchy (Ancestors)

Obstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Kotb A Metwalley, prof

    pediatrics Department, Assiut University Hospitals

    STUDY CHAIR

Central Study Contacts

Kamal G Ahmed, Resident

CONTACT

+20 11 41620746kamal.18313193@med.aun.edu.eg

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
30 Days
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident Physician, Department of pediatrics

Study Record Dates

First Submitted

September 2, 2026

First Posted

September 14, 2026

Study Start

September 20, 2026

Primary Completion (Estimated)

September 25, 2027

Study Completion (Estimated)

July 1, 2028

Last Updated

September 14, 2026

Record last verified: 2026-09