Extremely Low Birth WeightNCT00850902
Humidity Strategy to Decrease Morbidity and Mortality in Extremely Low Birth Weight Infants
A study testing High Humidity (HH) and Moderate Humidity in people with Extremely Low Birth Weight, run by King Fahad Medical City.
Trial summary
The purpose of this study is to apply a different incubator humidity strategy at birth to decrease morbidity and mortality in extremely low birth (1000 g or less) infants. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Extremely Low Birth Weight
- What is being tested?
- High Humidity (HH) and Moderate Humidity
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 700 participants
- Where
- No sites listed yet
- Study dates
- Mar 2009to Apr 2010
- Phase
- Interventional
- 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
Who may be able to join
- Inborn Premature Infants with weight ≤ 1000 g at birth
Who cannot join
- Outborn infants.
- Failure to obtain parental consent for the study.
- Congenital malformations likely to affect life expectancy or neurosensory development.
- Unlikely to be available for follow up.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Application of a Different Incubator Humidity Strategy at Birth to Decrease Morbidity and Mortality in Extremely Low Birth (1000 g or Less) Infants
The purpose of this study is to apply a different incubator humidity strategy at birth to decrease morbidity and mortality in extremely low birth (1000 g or less) infants.
- Conditions
- Extremely Low Birth Weight
- Being tested
- High Humidity (HH), Moderate Humidity
- Keywords
- ELBW, Humidity, BPD
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High Humidity (HH)Other
High Humidity Level
Moderate HumidityOther
Moderate Humidity Level
| Study group | Role | What they receive |
|---|---|---|
| Moderate Humidity (MH) | Active comparator | Not described Receives: Other: Moderate Humidity |
| High Humidity | Experimental | Not described Receives: Other: High Humidity (HH) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Death prior to discharge or Bronchopulmonary Dysplasia (BPD) defined as oxygen requirement at 36 weeks postmenstrual age.
Measured: 36 weeks postmenstrual age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2009 (estimated)
- Study startMar 2009
- Primary completionMar 2010 (estimated)
- Study completionApr 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Extremely Low Birth WeightStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 700 participants (estimated)
Sponsor and investigators
- Lead sponsor
- King Fahad Medical City
- Sponsor type
- Other government
- Investigators
- Jasim Anabrees, Principal investigator, King Fahad Medical City
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00850902
- Sponsor's protocol ID
- 08-049
- Status last verified
- Mar 2009
- First submitted
- 23 Feb 2009
- Last updated
- 10 Mar 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of a Different Incubator Humidity Strategy at Birth to Decrease Morbidity and Mortality in Extremely Low Birth (1000 g or Less) Infants
- ClinicalTrials.gov ID
- NCT00850902
- Acronym / sponsor ID
- 08-049
- Conditions
- Extremely Low Birth Weight
- Keywords
- ELBW, Humidity, BPD
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 700 participants (estimated)
- Lead sponsor
- King Fahad Medical CityOther government
- Study start
- Mar 2009
- Primary completion
- Mar 2010 (estimated)
- Study completion
- Apr 2010 (estimated)
- First posted
- 25 Feb 2009 (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 apply a different incubator humidity strategy at birth to decrease morbidity and mortality in extremely low birth (1000 g or less) infants.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Moderate Humidity (MH) | Active comparator | Other: Moderate Humidity |
| High Humidity | Experimental | Other: High Humidity (HH) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Inborn Premature Infants with weight ≤ 1000 g at birth
Key exclusion criteria (4 listed)
- Outborn infants.
- Failure to obtain parental consent for the study.
- Congenital malformations likely to affect life expectancy or neurosensory development.
- Unlikely to be available for follow up.
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 |
|---|---|---|
| High Humidity (HH)High Humidity Level | Other | High Humidity |
| Moderate HumidityModerate Humidity Level | Other | Moderate Humidity (MH) |
Primary outcome
Death prior to discharge or Bronchopulmonary Dysplasia (BPD) defined as oxygen requirement at 36 weeks postmenstrual age.
Time frame: 36 weeks postmenstrual age
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2009.
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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.
Jasim Anabrees principal investigator
King Fahad Medical City
Questions about this trial
What is this clinical trial studying?
A study testing High Humidity (HH) and Moderate Humidity in people with Extremely Low Birth Weight, run by King Fahad Medical City.
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 1 inclusion and 4 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 10 Mar 2009. Status can change between updates, so confirm with the study contact before making plans.
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 Jasim Anabrees (+966 590 591 102, jasim1800@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Death prior to discharge or Bronchopulmonary Dysplasia (BPD) defined as oxygen requirement at 36 weeks postmenstrual age. (time frame: 36 weeks postmenstrual age). 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 10 Mar 2009.