NCT04333121

Brief Summary

The aim of this study is to model longitudinal data at NICU of Assuit University Children Hospital to create predictive growth charts for weight in preterm infants from birth till discharge, that take into account the differing growth rates post-birth when compared to in-utero growth ,and to compare it with WHO chart for preterms.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2020

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 1, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 3, 2020

Completed
8 months until next milestone

Study Start

First participant enrolled

December 1, 2020

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2022

Completed
Last Updated

April 3, 2020

Status Verified

April 1, 2020

Enrollment Period

1 year

First QC Date

April 1, 2020

Last Update Submit

April 1, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • Modelling predictive gender-and gestation-specific weight reference centiles for preterm infants using a population-based cohort study at neonatology unit of Assuit University Children Hospital

    It is an observational retrospective study achieved by collecting retrospective, longitudinal measurements of weight from preterm infants born at \<34 weeks gestation, starting from birth, and model gender- and gestation specific predictive centile charts till discharge from the neonatal unit by a population-based cohort study.

    one year

Interventions

weightOTHER

we can monitoring the growth of the infants by weight gain degree

Eligibility Criteria

Age1 Day - 1 Month
Sexall(Gender-based eligibility)
Gender Eligibility Detailswe will compare the difference of weight gain between males and females infants
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

It is an observational retrospective study achieved by collecting retrospective, longitudinal measurements of weight from preterm infants born at \<34 weeks gestation, starting from birth, and model gender- and gestation specific predictive centile charts till discharge from the neonatal unit by a population-based cohort study.

You may qualify if:

  • Data will be collected for all infants born at \<34 weeks of gestation who were delivered by vaginal or caesarian section and born at Assuit University Hospital or referred to it.

You may not qualify if:

  • (1) Any neonate born at 34 weeks of gestation or more, (2) any neonate born at \<34 weeks of gestation who died before a second weight could be recorded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • Dusick AM, Poindexter BB, Ehrenkranz RA, Lemons JA. Growth failure in the preterm infant: can we catch up? Semin Perinatol. 2003 Aug;27(4):302-10. doi: 10.1016/s0146-0005(03)00044-2.

    PMID: 14510321BACKGROUND
  • Secher NJ, Kern Hansen P, Thomsen BL, Keiding N. Growth retardation in preterm infants. Br J Obstet Gynaecol. 1987 Feb;94(2):115-20. doi: 10.1111/j.1471-0528.1987.tb02336.x.

    PMID: 3548805BACKGROUND

MeSH Terms

Conditions

Premature Birth

Interventions

Weights and Measures

Condition Hierarchy (Ancestors)

Obstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Intervention Hierarchy (Ancestors)

Investigative Techniques

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Modelling predictive gender-and gestation-specific weight reference centiles for preterm infants using a population-based cohort study at neonatology unit of Assuit University Children Hospital

Study Record Dates

First Submitted

April 1, 2020

First Posted

April 3, 2020

Study Start

December 1, 2020

Primary Completion

December 1, 2021

Study Completion

January 1, 2022

Last Updated

April 3, 2020

Record last verified: 2020-04