Low; Birthweight, Extremely (999 Grams or Less)NCT03757780
Low Birth Weight Fetuses With Caffeine Use
An observational study of Low; Birthweight, Extremely (999 Grams or Less), run by Aljazeera Hospital at 1 site in Egypt.
Trial summary
Globally, it has been estimated that 15.5% of all infantsare born low birth weight, defined as birthweight less than 2,500 g . Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Low; Birthweight, Extremely (999 Grams or Less)
- What is being tested?
- Questionaire
- How many people
- 500 participants
- Where
- 1 siteEgypt
- Study dates
- 30 Nov 2018to 15 Feb 2019
- 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 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Age group: 18-40 •Pregnant females attending regular post-natal care visits
Who may be able to join
- Age group: 18-40
- Pregnant females attending regular post-natal care visits
Who cannot join
- • Female patients with other acute or chronic illness
- Cardiovascular disease
- Neoplasms
- Current diabetes mellitus, pregnancy induced diabetes
- Renal impairment (serum creatinine 120 mol/liter), and hypertension (blood pressure 140/85 mm Hg).
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Algazeerah and Kasralainy hospital
Giza
Mahmoud Alalfy, master, +201002611058, mahmoudalalfy@ymail.com
Ahmed Elgazzar, M.D, +201014005959
About this study
Official title: Association of Low Birth Weight Fetuses With Caffeine Use
Globally, it has been estimated that 15.5% of all infantsare born low birth weight, defined as birthweight less than 2,500 g .
Read the detailed description
Low birth weight is not only associated with neonatal mortality and morbidity.
but also with a higher risk of chronic diseases such as type 2 diabetes and cardiovascular diseases in adult life
- Being tested
- Questionaire
- Medical subject headings
- Birth Weight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionaireOther
A questionaire will be made to pregnant ladies who take caffeine during pregnancy
| Study group | Role | What they receive |
|---|---|---|
| Pregnant ladies who are caffeine using | ladies who uses caffeine during pregnancy Receives: Other: Questionaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of pregnant ladies who will have low birth weight babies
Mothers who will give birth to low birth weight infants
Measured: within 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2018
- Study start30 Nov 2018
- Primary completion1 Feb 2019 (estimated)
- Study completion15 Feb 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low; Birthweight, Extremely (999 Grams or Less)Studies of the same condition, open and under way.
- 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
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aljazeera Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Kasr El Aini Hospital
- Responsible party
- Sponsor
- Investigators
- Mahmoud Alalfy, Study chair, Algazeerah hospital -Location (Giza -Egypt ) and National Research centre egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03757780
- Sponsor's protocol ID
- low birth weight
- Status last verified
- Jan 2019
- First submitted
- 27 Nov 2018
- Last updated
- 9 Jan 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association of Low Birth Weight Fetuses With Caffeine Use
- ClinicalTrials.gov ID
- NCT03757780
- Acronym / sponsor ID
- low birth weight
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Aljazeera HospitalUniversity, hospital or other
- Collaborators
- Kasr El Aini Hospital
- Study start
- 30 Nov 2018 (actual)
- Primary completion
- 1 Feb 2019 (estimated)
- Study completion
- 15 Feb 2019 (estimated)
- First posted
- 29 Nov 2018 (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.
Globally, it has been estimated that 15.5% of all infantsare born low birth weight, defined as birthweight less than 2,500 g .
Detailed description
Low birth weight is not only associated with neonatal mortality and morbidity.
but also with a higher risk of chronic diseases such as type 2 diabetes and cardiovascular diseases in adult life
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pregnant ladies who are caffeine using | – | Other: Questionaireladies who uses caffeine during pregnancy |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Age group: 18-40 •Pregnant females attending regular post-natal care visits
Key inclusion criteria (2 listed)
- Age group: 18-40
- Pregnant females attending regular post-natal care visits
Key exclusion criteria (5 listed)
- • Female patients with other acute or chronic illness
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 |
|---|---|---|
| QuestionaireA questionaire will be made to pregnant ladies who take caffeine during pregnancy | Other | Pregnant ladies who are caffeine using |
Primary outcome
The number of pregnant ladies who will have low birth weight babies
Time frame: within 2 months
Mothers who will give birth to low birth weight infants
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2019.
- Individual participant dataSharing planned: No
Related trials for Low; Birthweight, Extremely (999 Grams or Less)
Recruiting
Effect of Support for Low-Income Mothers of Preterm Infants
Preterm Birth, Low; Birthweight, Extremely (999 Grams or Less)
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.
Mahmoud Alalfy study chair
Algazeerah hospital -Location (Giza -Egypt ) and National Research centre egypt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Low; Birthweight, Extremely (999 Grams or Less), run by Aljazeera Hospital at 1 site in Egypt.
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 2 inclusion and 5 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 9 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Mahmoud Alalfy (01002611058, mahmoudalalfy@ymail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The number of pregnant ladies who will have low birth weight babies (time frame: within 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Jan 2019.