- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04333121
Modelling Weight Reference Centiles for Preterm Infants
April 1, 2020 updated by: Mohammed Khalaf Ali, Assiut University
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
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.
Study Overview
Detailed Description
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.
Study Type
Observational
Enrollment (Anticipated)
100
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Mohamed Khalaf
- Phone Number: +201002424743
- Email: mohammedkhalaf896@yahoo.com
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
1 day to 1 month (CHILD)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
All
Sampling Method
Non-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.
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- (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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
Time Frame: one year
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ANTICIPATED)
December 1, 2020
Primary Completion (ANTICIPATED)
December 1, 2021
Study Completion (ANTICIPATED)
January 1, 2022
Study Registration Dates
First Submitted
April 1, 2020
First Submitted That Met QC Criteria
April 1, 2020
First Posted (ACTUAL)
April 3, 2020
Study Record Updates
Last Update Posted (ACTUAL)
April 3, 2020
Last Update Submitted That Met QC Criteria
April 1, 2020
Last Verified
April 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- weight chart for preterms
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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