Respiratory DistressNCT00550069
Observational Study of Infants Born at 34 to 37 Weeks of Gestation Until the Age of 1 Year
An observational study of Respiratory Distress and Hypoglycemia, run by Sheba Medical Center at 1 site in Israel.
Trial summary
Late preterm infants are at an increased risk for short and long term morbidity (during the 1st year of life, their neurodevelopmental status may also be delayed as compared to infants born at term). The term "near term infants" is probably a deceiving one. Read more about this study
- Who is it for?
- Ages 1 hour to 30 daysHealthy volunteers can take part
- Conditions the study is for
- Respiratory Distress, Hypoglycemia, Feeding Intolerance
- How many people
- 300 participants
- Where
- 1 siteIsrael
- Study dates
- Dec 2007to Jan 2009
- 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 hour to 30 days
- All sexes
- Healthy volunteers accepted
- Child
Study population: All infants born at a gestational age of 34-37 weeks in 3 medical centers in Israel
Who may be able to join
- Gestational age 34wks- 37wks
- Singleton
- Without chromosomal abnormalities or malformations
Who cannot join
- No chromosomal abnormalities
- Malformations
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Late Preterm Infants:Clinical Course and Outcome From Birth Through Out the First Year of Life.
Late preterm infants are at an increased risk for short and long term morbidity (during the 1st year of life, their neurodevelopmental status may also be delayed as compared to infants born at term). The term "near term infants" is probably a deceiving one.
Read the detailed description
The study will include all near term infants born at 3 Israeli medical centers during a one year period.
- Conditions
- Respiratory Distress, Hypoglycemia, Feeding Intolerance, Jaundice, Hypothermia, Developmental Delay
- Keywords
- late preterm infants, near term infants, outcome
- Medical subject headings
- Dyspnea, Hypoglycemia, Jaundice, Hypothermia, Learning Disabilities
What is being measured
The primary outcome is the main question the study is designed to answer.
neurodevelopmental, health and growth status in late preterm infants vs. controls within the first year of life
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 posted26 Oct 2007 (estimated)
- Study startDec 2007
- Study completionJan 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory DistressStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
- Investigators
- Iris Morag, M.D, Principal investigator, Sheba Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00550069
- Sponsor's protocol ID
- SHEBA-07-4821-IM-CTIL
- Status last verified
- Dec 2007
- First submitted
- 25 Oct 2007
- Last updated
- 27 Dec 2007
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Late Preterm Infants:Clinical Course and Outcome From Birth Through Out the First Year of Life.
- ClinicalTrials.gov ID
- NCT00550069
- Acronym / sponsor ID
- SHEBA-07-4821-IM-CTIL
- Conditions
- Respiratory Distress, Hypoglycemia, Feeding Intolerance, Jaundice, Hypothermia, Developmental Delay
- Keywords
- late preterm infants, near term infants, outcome
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Sheba Medical CenterOther government
- Study start
- Dec 2007
- Study completion
- Jan 2009 (estimated)
- First posted
- 26 Oct 2007 (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.
Late preterm infants are at an increased risk for short and long term morbidity (during the 1st year of life, their neurodevelopmental status may also be delayed as compared to infants born at term). The term "near term infants" is probably a deceiving one.
Detailed description
The study will include all near term infants born at 3 Israeli medical centers during a one year period.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 1 hour to 30 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- All infants born at a gestational age of 34-37 weeks in 3 medical centers in Israel
Key inclusion criteria (3 listed)
- Gestational age 34wks- 37wks
- Singleton
- Without chromosomal abnormalities or malformations
Key exclusion criteria (2 listed)
- No chromosomal abnormalities
- Malformations
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
neurodevelopmental, health and growth status in late preterm infants vs. controls within the first year of life
Time frame: one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2007.
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Assessment of Blood Viscosity in ARDS (Acute Respiratory Distress Syndrome)
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Recruiting
Comparing Surfactant Administration Through Supraglottic Airway and Thin Catheter for Preterm Infants
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REspiratory MEchanics for Delivering Individualised Exogenous Surfactant
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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.
Iris Morag, M.D principal investigator
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 Respiratory Distress and Hypoglycemia, 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 3 inclusion and 2 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 27 Dec 2007. 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 Iris Morag, MD (+972-52-666-7393, irismorag@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
neurodevelopmental, health and growth status in late preterm infants vs. controls within the first year of life (time frame: one year). 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 27 Dec 2007.