Small for Gestational Age InfantsNCT02887664
The Correlation Between the n-6:n-3 Ratio and Inflammatory Markers in Small for Gestational Age (SGA) Infants Compared With Appropriate for Gestational Age (AGA) Infants
An observational study of Small for Gestational Age Infants and Appropriate for Gestational Age Infants, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.
Trial summary
Numerous studies have recommended the use of n-3 PUFA supplementation during human pregnancy and lactation for the prevention of preterm birth, beneficial effects on fetal development, visual and cognitive development and other functional outcomes of the infants. Read more about this study
- Who is it for?
- Ages 18 to 60 years, women only
- Conditions the study is for
- Small for Gestational Age Infants, Appropriate for Gestational Age Infants
- What is being tested?
- Blood test
- Type of treatment
- Surgery or procedure
- How many people
- 60 participants
- Where
- 1 siteIsrael
- Study dates
- 2 Oct 2018to Dec 2020
- 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 60 years
- Women only
- No healthy volunteers
- Adult
Study population: Mothers of term or or near term infants after delivery
Who may be able to join
- Mothers of SGA infants ( above 35 week of gestation)
- Mothers of term and near-term AGA infants
Who cannot join
- Maternal chronic diseases, smoking, diabetes, alcohol use, pregnancy-associated hypertension and pre-eclampsia
- Neonatal depression
- Congenital malformations
- Intrauterine infections
- Chromosomal aberrations
- Mothers interested in cord blood banking
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Sourasky medical center (Ichilov)
Tel Aviv
About this study
Numerous studies have recommended the use of n-3 PUFA supplementation during human pregnancy and lactation for the prevention of preterm birth, beneficial effects on fetal development, visual and cognitive development and other functional outcomes of the infants.
The aim of the present study is to assess the correlation between ratio of n-3:n-6 fatty acid and inflammation markers in SGA infants compared with appropriate for gestational age (AGA) infants. The investigators hypothesize that in SGA infants n-3 and n-6 fatty acid concentrations in cord blood will differ from those observed in AGA and might correlate with the level of circulating mediators.
- Being tested
- Blood test
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood testProcedure or surgery
Blood will be drawn from mother's vein and from the cord to test for n-6:n-3 ratio and inflammatory markers: CRP, IL-6, TPO and TNF-alpha markers
| Study group | Role | What they receive |
|---|---|---|
| Blood test in Mothers of SGA Infants | In mothers of Small for Gestational Age (SGA) Infants, maternal and cord blood test will be performed Receives: Procedure: Blood test | |
| Blood test in Mothers of AGA infants | In mothers of Appropriate for Gestational Age (AGA) Infants, maternal and cord blood test will be performed Receives: Procedure: Blood test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cord blood analysis
Determination of the cord blood values of inflammatory markers (CRP, IL-6, TPO, TNF-alpha) and of the n-6:n-3 ratio
Measured: at time of delivery
Secondary outcomes (1)
Maternal blood analysis
Determination of the maternal blood values of inflammatory markers (CRP, IL-6, TPO, TNF-alpha) and of n-6:n-3 ratio
Measured: at time of delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2016 (estimated)
- Study start2 Oct 2018
- Primary completionDec 2020 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Small for Gestational Age InfantsStudies 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tel-Aviv Sourasky Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Dror Mandel, MD, Principal investigator, Department of Neonatology, Lis Maternity Hospital, Tel Aviv Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02887664
- Sponsor's protocol ID
- 0285-16-TLV-DM
- Status last verified
- Jul 2019
- First submitted
- 22 Aug 2016
- Last updated
- 18 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Correlation Between the n-6:n-3 Ratio and Inflammatory Markers in Small for Gestational Age (SGA) Infants Compared With Appropriate for Gestational Age (AGA) Infants
- ClinicalTrials.gov ID
- NCT02887664
- Acronym / sponsor ID
- 0285-16-TLV-DM
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Tel-Aviv Sourasky Medical CenterOther government
- Study start
- 2 Oct 2018 (actual)
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 2 Sep 2016 (estimated)
- 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.
Numerous studies have recommended the use of n-3 PUFA supplementation during human pregnancy and lactation for the prevention of preterm birth, beneficial effects on fetal development, visual and cognitive development and other functional outcomes of the infants.
The aim of the present study is to assess the correlation between ratio of n-3:n-6 fatty acid and inflammation markers in SGA infants compared with appropriate for gestational age (AGA) infants. The investigators hypothesize that in SGA infants n-3 and n-6 fatty acid concentrations in cord blood will differ from those observed in AGA and might correlate with the level of circulating mediators.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Blood test in Mothers of SGA Infants | – | Procedure: Blood testIn mothers of Small for Gestational Age (SGA) Infants, maternal and cord blood test will be performed |
| Blood test in Mothers of AGA infants | – | Procedure: Blood testIn mothers of Appropriate for Gestational Age (AGA) Infants, maternal and cord blood test will be performed |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Mothers of term or or near term infants after delivery
Key inclusion criteria (2 listed)
- Mothers of SGA infants ( above 35 week of gestation)
- Mothers of term and near-term AGA infants
Key exclusion criteria (6 listed)
- Maternal chronic diseases, smoking, diabetes, alcohol use, pregnancy-associated hypertension and pre-eclampsia
- Neonatal depression
- Congenital malformations
- Intrauterine infections
- Chromosomal aberrations
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 |
|---|---|---|
| Blood testBlood will be drawn from mother's vein and from the cord to test for n-6:n-3 ratio and inflammatory markers: CRP, IL-6, TPO and TNF-alpha markers | Procedure or surgery | Blood test in Mothers of AGA infants, Blood test in Mothers of SGA Infants |
Primary outcome
Cord blood analysis
Time frame: at time of delivery
Determination of the cord blood values of inflammatory markers (CRP, IL-6, TPO, TNF-alpha) and of the n-6:n-3 ratio
1 secondary outcome
Maternal blood analysis
Time frame: at time of delivery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2019.
- Individual participant dataSharing planned: No
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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.
Dror Mandel, MD principal investigator
Department of Neonatology, Lis Maternity Hospital, Tel Aviv Medical Center
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 Small for Gestational Age Infants and Appropriate for Gestational Age Infants, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.
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 6 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 18 Jul 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 Israel. 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 Dror Mandel, MD (+97236925690, drorm@tlvmc.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cord blood analysis (time frame: at time of delivery). 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 18 Jul 2019.