Preterm InfantsNCT01430832
Developmental Outcomes of Extreme Prematurity, 5-15 Years Postpartum
An observational study of Preterm Infants and Post Traumatic Stress Disorder, run by Sheba Medical Center at 1 site in Israel.
Trial summary
The purpose of this study is to assess the emotional well being of mothers to preterm infants with ELBW 5-15 years after the birth. Post-traumatic symptoms and parental stress levels will be taken into consideration. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Preterm Infants, Post Traumatic Stress Disorder, Emotional Stress
- How many people
- 95 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Sep 2011to Nov 2011
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Participants are children born at Sheba Medical center between the years 1995-2006.
Who may be able to join
- Preterm Infant
- Very low birth weight or extremely low birth weight
Who cannot join
- Missing information regarding birth week and weight
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Long-Term Developmental Outcomes of Extreme Prematurity: Correlations With Maternal Post-Traumatic Symptoms, Parental Stress and Post-Traumatic Growth, 5-15 Years Postpartum
The purpose of this study is to assess the emotional well being of mothers to preterm infants with ELBW 5-15 years after the birth. Post-traumatic symptoms and parental stress levels will be taken into consideration. In addition, the correlation between the infant's development and the mother's emotional state will be analyzed.
Read the detailed description
Medical records of the children will be used for information in four categories: prenatal, birth, development,and demographic information. Parents will be contacted and interviewed regarding the child's development. In addition, they will complete the following questionnaires: PPQ-II Perinatal PTSD Questionnaire- modified, PTGI -The Posttraumatic Growth Inventory,Parental Stress Index- Short Form- PSI-SF, and Life Events questionnaire.
- Conditions
- Preterm Infants, Post Traumatic Stress Disorder, Emotional Stress, Infant, Very Low Birth Weight
- Keywords
- PTSD, Preterm, Premature, VLBW
- Medical subject headings
- Stress Disorders, Post-Traumatic, Stress, Psychological, Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Normal Development | The infant's development level will be assessed using a phone interview with parents | |
| Abnormal Development | The infant's level of development will be assessed using a phone interview with parents |
What is being measured
The primary outcome is the main question the study is designed to answer.
Not relevant
Measured: Not relevant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2011 (estimated)
- Study start1 Sep 2011
- Primary completion1 Nov 2011
- Study completionNov 2011
Why it stopped: Recruitment Status
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preterm InfantsStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 95 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Lidia Gabis, MD, Principal investigator, Sheba Medical CenterGabi Zerach, Ph.D, Principal investigator, Ariel UniversityShefer Shahar, Ph.D, Study director, Sheba Medical CenterAdi Elsing, BA, Study director, Sheba Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01430832
- Sponsor's protocol ID
- SHEBA-10-8121-LG-CTIL
- Status last verified
- Jun 2018
- First submitted
- 7 Sep 2011
- Last updated
- 2 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Long-Term Developmental Outcomes of Extreme Prematurity: Correlations With Maternal Post-Traumatic Symptoms, Parental Stress and Post-Traumatic Growth, 5-15 Years Postpartum
- ClinicalTrials.gov ID
- NCT01430832
- Acronym / sponsor ID
- SHEBA-10-8121-LG-CTIL
- Conditions
- Preterm Infants, Post Traumatic Stress Disorder, Emotional Stress, Infant, Very Low Birth Weight
- Keywords
- PTSD, Preterm, Premature, VLBW
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Recruitment Status
- Enrolment
- 95 participants (actual)
- Lead sponsor
- Sheba Medical CenterOther government
- Study start
- 1 Sep 2011
- Primary completion
- 1 Nov 2011 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 8 Sep 2011 (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.
The purpose of this study is to assess the emotional well being of mothers to preterm infants with ELBW 5-15 years after the birth. Post-traumatic symptoms and parental stress levels will be taken into consideration. In addition, the correlation between the infant's development and the mother's emotional state will be analyzed.
Detailed description
Medical records of the children will be used for information in four categories: prenatal, birth, development,and demographic information. Parents will be contacted and interviewed regarding the child's development. In addition, they will complete the following questionnaires: PPQ-II Perinatal PTSD Questionnaire- modified, PTGI -The Posttraumatic Growth Inventory,Parental Stress Index- Short Form- PSI-SF, and Life Events questionnaire.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Normal Development | – | –The infant's development level will be assessed using a phone interview with parents |
| Abnormal Development | – | –The infant's level of development will be assessed using a phone interview with parents |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Participants are children born at Sheba Medical center between the years 1995-2006.
Key inclusion criteria (2 listed)
- Preterm Infant
- Very low birth weight or extremely low birth weight
Key exclusion criteria (1 listed)
- Missing information regarding birth week and weight
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 relevant
Time frame: Not relevant
Results and safety
The study was stopped early (reason given: Recruitment Status). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2018.
- Individual participant dataSharing planned: Undecided
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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.
Lidia Gabis, MD principal investigator
Sheba Medical Center
Gabi Zerach, Ph.D principal investigator
Ariel University
Shefer Shahar, Ph.D 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 Preterm Infants and Post Traumatic Stress Disorder, 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: stopped early, as of the sponsor's last update on 2 Jul 2018. 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?
The study was stopped early (reason given: Recruitment Status). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Not relevant (time frame: Not relevant). 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 2 Jul 2018.