Pre-TermNCT04333121
Modelling Weight Reference Centiles for Preterm Infants
An observational study of Pre-Term, run by Assiut University.
Trial 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… Read more about this study
- Who is it for?
- Ages 1 day to 1 month
- Conditions the study is for
- Pre-Term
- What is being tested?
- weight
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2020to 1 Jan 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
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 1 day to 1 month
- All sexes
- Child
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.
Who may be able to join
- 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.
Who cannot join
- (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.
Trial locations and contacts
No sites are listed yet.
About this study
Official 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
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.
Read the 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.
- Conditions
- Pre-Term
- Being tested
- weight
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
weightOther
we can monitoring the growth of the infants by weight gain degree
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2020
- Study start1 Dec 2020 (estimated)
- Primary completion1 Dec 2021 (estimated)
- Study completion1 Jan 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Pre-TermStudies 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
- Retrospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohammed Khalaf Ali, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04333121
- Sponsor's protocol ID
- weight chart for preterms
- Status last verified
- Apr 2020
- First submitted
- 1 Apr 2020
- Last updated
- 3 Apr 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 14510321Secher 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.
PubMed 3548805
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT04333121
- Acronym / sponsor ID
- weight chart for preterms
- Conditions
- Pre-Term
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Dec 2020 (estimated)
- Primary completion
- 1 Dec 2021 (estimated)
- Study completion
- 1 Jan 2022 (estimated)
- First posted
- 3 Apr 2020 (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.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 1 day to 1 month
- Sex
- All
- Age groups
- Child
- 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.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- (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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| weightwe can monitoring the growth of the infants by weight gain degree | Other | – |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2020.
- Background: PubMed 14510321Dusick 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.
- Background: PubMed 3548805Secher 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.
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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. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Pre-Term, 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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 3 Apr 2020. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mohamed Khalaf (+201002424743, mohammedkhalaf896@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04333121, which also lists 2 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 3 Apr 2020.