- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving 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
Studieoversikt
Status
Detaljert beskrivelse
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.
Studietype
Registrering (Antatt)
Kontakter og plasseringer
Studiekontakt
- Navn: Kamal G Ahmed, Resident
- Telefonnummer: +20 11 41620746
- E-post: kamal.18313193@med.aun.edu.eg
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Barn
Tar imot friske frivillige
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
|---|
|
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.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Occurrence of postnatal growth failure
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Growth velocity
Tidsramme: 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
Tidsramme: 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
Tidsramme: Up to 30 days
|
Number of days of parenteral nutrition during hospitalization.
|
Up to 30 days
|
|
Length of hospital stay
Tidsramme: Up to 30 days
|
Duration of hospitalization in days.
|
Up to 30 days
|
|
In-hospital mortality
Tidsramme: Up to 30 days
|
Rate of mortality during the NICU stay.
|
Up to 30 days
|
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Studiestol: Kotb A Metwalley, prof, pediatrics Department, Assiut University Hospitals
Publikasjoner og nyttige lenker
Generelle publikasjoner
- 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.
Studierekorddatoer
Studer hoveddatoer
Studiestart (Antatt)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- PGF-Preterm-NICU-Assiut-2026
Legemiddel- og utstyrsinformasjon, studiedokumenter
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