TwinsNCT00320840
Internal and Familial Resources and Motherhood. Follow Up of Mothers With Twins and Preterm Infants Versus Mothers With Single Full Term Infants
An observational study of Twins and Preterm Infants, run by Sheba Medical Center at 1 site in Israel.
Trial summary
To evaluate the contribution of internal and familial resources on the development of motherhood in a population of mothers having preterm twin infants and comparing this population to a population of mothers giving birth to single (or twins) full term infants. Read more about this study
- Who is it for?
- Ages 2 weeks to 3 months
- Conditions the study is for
- Twins, Preterm Infants
- How many people
- 150 participants
- Where
- 1 siteIsrael
- Study dates
- May 2006to May 2012
- 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 2 weeks to 3 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- preterm infants
- twins
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
Israel1 site
Sheba medical center - Neonatal Department
Ramat Gan, 52621
Jacob Kuint, MD, 972-3-5302227, kuint-j@sheba.health.gov.il
About this study
Official title: The Contribution of Internal and Familial Resources to the Development of Motherhood. Long Term Follow Up of Mothers With Twins and Preterm Infants Versus Mothers With Single Full Term Infants
To evaluate the contribution of internal and familial resources on the development of motherhood in a population of mothers having preterm twin infants and comparing this population to a population of mothers giving birth to single (or twins) full term infants.
Read the detailed description
150 mothers will participate in this study. The study is using 4 questionnaires at infants ages of 1 month, 1 year, 2 years and 4 years. The questionnaires are involving communication skills,grandparents support, stress feelings, psychological parameters, parity functioning, infant temperament, self assessment, maternal and infant medical background and twins and brotherhood evaluation.
a comparison will be done between mothers to preterm twins and mothers to single full term infants.
- Conditions
- Twins, Preterm Infants
- Keywords
- preterm infants, twins, motherhood, internal resources, familial resources
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2006 (estimated)
- Study startMay 2006
- Study completionMay 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TwinsStudies of the same condition, open and under way.
- More trials run by Sheba Medical CenterThe 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
- Defined population
- Time perspective
- Prospective
- Enrolment
- 150 participants
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
- Investigators
- Jacob Kuint, MD, Study director, Sheba Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00320840
- Sponsor's protocol ID
- SHEBA-06-4131-JK-CTIL
- Status last verified
- Apr 2006
- First submitted
- 30 Apr 2006
- Last updated
- 3 May 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Contribution of Internal and Familial Resources to the Development of Motherhood. Long Term Follow Up of Mothers With Twins and Preterm Infants Versus Mothers With Single Full Term Infants
- ClinicalTrials.gov ID
- NCT00320840
- Acronym / sponsor ID
- SHEBA-06-4131-JK-CTIL
- Conditions
- Twins, Preterm Infants
- Keywords
- preterm infants, twins, motherhood, internal resources, familial resources
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants
- Lead sponsor
- Sheba Medical CenterOther government
- Study start
- May 2006
- Study completion
- May 2012
- First posted
- 3 May 2006 (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.
To evaluate the contribution of internal and familial resources on the development of motherhood in a population of mothers having preterm twin infants and comparing this population to a population of mothers giving birth to single (or twins) full term infants.
Detailed description
150 mothers will participate in this study. The study is using 4 questionnaires at infants ages of 1 month, 1 year, 2 years and 4 years. The questionnaires are involving communication skills,grandparents support, stress feelings, psychological parameters, parity functioning, infant temperament, self assessment, maternal and infant medical background and twins and brotherhood evaluation.
a comparison will be done between mothers to preterm twins and mothers to single full term infants.
Study design
- Observational model
- Defined population
- Time perspective
- Prospective
Who may qualify
- Ages
- 2 weeks to 3 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- preterm infants
- twins
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2006.
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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.
Jacob Kuint, MD study director
Sheba 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 Twins and Preterm Infants, run by Sheba 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 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 May 2006. 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 Jacob kuint, MD (972-3-5303030 ext. 2227, kuint-j@sheba.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
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 3 May 2006.