Premature BirthNCT00460044
ADMA and Mechanical Ventilation in Preterm Infants
An observational study of Premature Birth, run by Amsterdam UMC, location VUmc.
Trial summary
The purpose of this study is to study the relation between mechanical ventilation and ADMA concentrations at birth. Read more about this study
- Who is it for?
- Ages Up to 32 weeks
- Conditions the study is for
- Premature Birth
- How many people
- 35 participants
- Where
- No sites listed yet
- Study dates
- Jan 2002to Jul 2003
- 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 Up to 32 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Gestational age < 32 weeks
- Birth weight < 1500 gram
- Written informed consent of parents
Who cannot join
- Congenital abnormalities
- Chromosomal abnormalities
About this study
Official title: Plasma ADMA Concentrations at Birth and Mechanical Ventilation in Preterm Infants
The purpose of this study is to study the relation between mechanical ventilation and ADMA concentrations at birth.
Read the detailed description
Nitric oxide (NO) plays an important role in the normal development and maturation of the lungs. In addition, NO is an important mediator of vascular smooth muscle relaxation, ventilation perfusion matching, neurotransmission and host defence and bacteriostasis. Asymmetric dimethylarginine (ADMA) is an endogenous derivative of arginine that inhibits NOS and thereby the bioavailability of NO. Preterm infants have increased concentrations of ADMA. Therefore, inhibition of NO by increased concentrations of ADMA which could be associated with reduced pulmonary functioning.
- Conditions
- Premature Birth
- Keywords
- ADMA, Preterms, infants, mechanical ventilation, Preterm infants
- Medical subject headings
- Premature Birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2007 (estimated)
- Study startJan 2002
- Study completionJul 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Premature BirthStudies 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
- Defined population
- Time perspective
- Other
- Enrolment
- 35 participants
Sponsor and investigators
- Lead sponsor
- Amsterdam UMC, location VUmc
- Sponsor type
- University, hospital or other
- Investigators
- R M van Elburg, MD, PhD, Study director, Amsterdam UMC, location VUmc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00460044
- Sponsor's protocol ID
- HK0607
- Status last verified
- Apr 2007
- First submitted
- 11 Apr 2007
- Last updated
- 13 Apr 2007
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Plasma ADMA Concentrations at Birth and Mechanical Ventilation in Preterm Infants
- ClinicalTrials.gov ID
- NCT00460044
- Acronym / sponsor ID
- HK0607
- Conditions
- Premature Birth
- Keywords
- ADMA, Preterms, infants, mechanical ventilation, Preterm infants
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 35 participants
- Lead sponsor
- Amsterdam UMC, location VUmcUniversity, hospital or other
- Study start
- Jan 2002
- Study completion
- Jul 2003 (actual)
- First posted
- 13 Apr 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.
The purpose of this study is to study the relation between mechanical ventilation and ADMA concentrations at birth.
Detailed description
Nitric oxide (NO) plays an important role in the normal development and maturation of the lungs. In addition, NO is an important mediator of vascular smooth muscle relaxation, ventilation perfusion matching, neurotransmission and host defence and bacteriostasis. Asymmetric dimethylarginine (ADMA) is an endogenous derivative of arginine that inhibits NOS and thereby the bioavailability of NO. Preterm infants have increased concentrations of ADMA. Therefore, inhibition of NO by increased concentrations of ADMA which could be associated with reduced pulmonary functioning.
Study design
- Observational model
- Defined population
- Time perspective
- Other
Who may qualify
- Ages
- Up to 32 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Gestational age < 32 weeks
- Birth weight < 1500 gram
- Written informed consent of parents
Key exclusion criteria (2 listed)
- Congenital abnormalities
- Chromosomal abnormalities
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
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2007.
Related trials for Premature Birth
Not yet recruitingPhase 1
Oral GDC-0077 in Premature Ovarian Insufficiency
Primary Ovarian Insufficiency
Not yet recruiting
Effects of a Multisensory Intervention Program on the Term Behavior of the Very Premature Baby
Very Premature Baby
RecruitingPhase 3
Hormone Replacement Therapy in Adolescents With Premature Ovarian Insufficiency
Premature Ovarian Insufficiency
Enrolling by invitationObservational study
Assessment of Worldwide Acute Kidney Injury Epidemiology in Neonates 2.0
Acute Kidney Injury, Fluid Overload
Recruiting
The Effect of Breast Milk, 10% and 20% Dextrose on Pain and Physiological Variables During Heel Puncture in Infants
Newborn Care, Pain Management
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.
R M van Elburg, MD, PhD study director
Amsterdam UMC, location VUmc
Questions about this trial
What is this clinical trial studying?
An observational study of Premature Birth, run by Amsterdam UMC, location VUmc.
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: finished, as of the sponsor's last update on 13 Apr 2007. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
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 13 Apr 2007.