ClinicalTrials.gg
Not yet recruitingNCT07818681Updated Sep 14, 2026

Predictors of Postnatal Growth Failure in Preterm Infants

An observational study in Premature Birth, Growth Failure and Very Low Birth Weight Infant, sponsored by Assiut University. Not yet recruiting. Open to participants aged Up to 36 Weeks. Per ClinicalTrials.gov, last updated 2026-09-14.

Sponsored by Assiut University · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
120
Ages
Up to 36 Weeks
Sex
All
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Study 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.

Read the 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.

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Conditions studied

  • Premature Birth
  • Growth Failure
  • Very Low Birth Weight Infant

Keywords

  • Clinical predictors
  • Postnatal growth failure
  • Preterm infants
  • Neonatal intensive care
  • Nutritional predictors
  • Assiut
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In context

Premature Birth

2,550 studies on the registry are indexed under Premature Birth; 500 are open to participants now.

This study's planned enrollment of 120 is close to the median of 120 across 806 observational studies indexed under Premature Birth.

Browse Premature Birth studies →

Lead sponsor

Assiut University is the lead sponsor of 5,078 studies on the registry; 2,178 are open to participants now.

Of its 14 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Up to 36 Weeks
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 from parents or legal guardians

Exclusion criteria

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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
120 participants (estimated)
Target follow-up
30 Days
Patient registry
Yes

Groups and cohorts

  • 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.

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What researchers measure

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.

    Time frame: Up to 30 days

Secondary outcomes

  1. Growth velocity

    Growth velocity expressed as grams per kilogram per day (g/kg/day) during hospitalization

    Time frame: Up to 30 days

  2. Time to achieve full enteral feeding

    Number of days from birth to achievement of full enteral feeding (150 mL/kg/day).

    Time frame: Up to 30 days

  3. Duration of parenteral nutrition

    Number of days of parenteral nutrition during hospitalization.

    Time frame: Up to 30 days

  4. Length of hospital stay

    Duration of hospitalization in days.

    Time frame: Up to 30 days

  5. In-hospital mortality

    Rate of mortality during the NICU stay.

    Time frame: Up to 30 days

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Study locations

No study locations are listed for this record.

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References and documents

Publications

  • 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. PubMed 36705703 ↗
  • 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. PubMed 40534585 ↗
  • 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. PubMed 26439183 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 14, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07818681
Lead sponsor
Assiut University
Responsible party
Kamal Gamal Mohamed Ahmed (Resident Physician, Department of pediatrics, Assiut University) — Principal investigator
First posted
Sep 14, 2026
Start date
Sep 20, 2026 (estimated)
Primary completion
Sep 25, 2027 (estimated)
Completion
Jul 1, 2028 (estimated)
Last update
Sep 14, 2026

Study contacts

Kamal G Ahmed, Resident
Contact
kamal.18313193@med.aun.edu.eg
+20 11 41620746
Kotb A Metwalley, prof
study chair · pediatrics Department, Assiut University Hospitals

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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