Premature BirthNCT07818681
Predictors of Postnatal Growth Failure in Preterm Infants
An observational study of Premature Birth and Growth Failure, run by Assiut University.
Trial 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 more about this study
- Who is it for?
- Ages Up to 36 weeks
- Conditions the study is for
- Premature Birth, Growth Failure, Very Low Birth Weight Infant
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- 20 Sep 2026to 1 Jul 2028
- How long will I take part?
- 30 Days
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 36 weeks
- All sexes
- No healthy volunteers
- Child
Study population: Preterm infants admitted to the Neonatal Intensive Care Unit of Assiut University Children's Hospital.
Who may be able to join
- - 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
Who cannot join
- - 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Clinical and Nutritional Predictors of Postnatal Growth Failure in Preterm Infants Admitted to the Neonatal Intensive Care Unit of Assiut University Children's Hospital
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.
- Keywords
- Clinical predictors, Postnatal growth failure, Preterm infants, Neonatal intensive care, Nutritional predictors, Assiut
- Medical subject headings
- Premature Birth, Failure to Thrive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 30 days
Secondary outcomes (5)
Growth velocity
Growth velocity expressed as grams per kilogram per day (g/kg/day) during hospitalization
Measured: Up to 30 days
Time to achieve full enteral feeding
Number of days from birth to achievement of full enteral feeding (150 mL/kg/day).
Measured: Up to 30 days
Duration of parenteral nutrition
Number of days of parenteral nutrition during hospitalization.
Measured: Up to 30 days
Length of hospital stay
Duration of hospitalization in days.
Measured: Up to 30 days
In-hospital mortality
Rate of mortality during the NICU stay.
Measured: Up to 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2026
- Study start20 Sep 2026 (estimated)
- Primary completion25 Sep 2027 (estimated)
- Study completion1 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Premature BirthStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
- Target duration
- 30 Days
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kamal Gamal Mohamed Ahmed, Assiut University
- Investigators
- Kotb A Metwalley, prof, Study chair, pediatrics Department, Assiut University Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07818681
- Sponsor's protocol ID
- PGF-Preterm-NICU-Assiut-2026
- Status last verified
- Sep 2026
- First submitted
- 2 Sep 2026
- Last updated
- 14 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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 36705703Fenton 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 40534585Guffey 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
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Nutritional Predictors of Postnatal Growth Failure in Preterm Infants Admitted to the Neonatal Intensive Care Unit of Assiut University Children's Hospital
- ClinicalTrials.gov ID
- NCT07818681
- Acronym / sponsor ID
- PGF-Preterm-NICU-Assiut-2026
- Keywords
- Clinical predictors, Postnatal growth failure, Preterm infants, Neonatal intensive care, Nutritional predictors, Assiut
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 20 Sep 2026 (estimated)
- Primary completion
- 25 Sep 2027 (estimated)
- Study completion
- 1 Jul 2028 (estimated)
- First posted
- 14 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 30 Days
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- Up to 36 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Preterm infants admitted to the Neonatal Intensive Care Unit of Assiut University Children's Hospital.
Key inclusion criteria (5 listed)
- - 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
Key exclusion criteria (6 listed)
- - Major congenital malformations
- Chromosomal abnormalities
- Major congenital gastrointestinal anomalies interfering with feeding
- Major congenital heart diseases requiring early surgical intervention
- Inborn errors of metabolism
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
5 secondary outcomes
Growth velocity
Time frame: Up to 30 days
Time to achieve full enteral feeding
Time frame: Up to 30 days
Duration of parenteral nutrition
Time frame: Up to 30 days
Length of hospital stay
Time frame: Up to 30 days
In-hospital mortality
Time frame: Up to 30 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2026.
- Background: PubMed 36705703Embleton 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.
- Background: PubMed 40534585Fenton 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.
- Background: PubMed 26439183Guffey 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kotb A Metwalley, prof study chair
pediatrics Department, Assiut University Hospitals
Questions about this trial
What is this clinical trial studying?
An observational study of Premature Birth and Growth Failure, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 14 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kamal G Ahmed, Resident (+20 11 41620746, kamal.18313193@med.aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of postnatal growth failure (time frame: Up to 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07818681, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2026.