Term Delivery With Preterm Labor, Third TrimesterNCT01722760
Tidal Neonatal NO, Vitamins A and D, and Infant Lung Disease - The AD-ON Study
An observational study of Term Delivery With Preterm Labor, Third Trimester and Term Delivery With Preterm Labor, Unspecified Trimester, run by Hillerod Hospital, Denmark at 2 sites in Denmark.
Trial summary
Children born prematurely are of greater risk of developing chronic lung disease (Bronchopulmonary Dysplasia). With an increase in the amount of premature children, we expect an increasing number of children with BPD. Read more about this study
- Who is it for?
- Ages Up to 2 daysHealthy volunteers can take part
- Conditions the study is for
- Term Delivery With Preterm Labor, Third Trimester, Term Delivery With Preterm Labor, Unspecified Trimester, Bronchopulmonary Dysplasia
- What is being tested?
- measurements
- Type of treatment
- Surgery or procedure
- How many people
- 1,500 participants
- Where
- 2 sitesDenmark
- Study dates
- Aug 2013to Nov 2015
- 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 2 days
- All sexes
- Healthy volunteers accepted
- Child
Study population: Term and preterm infants admitted to Neonatal Care Unit for reference material as control group. Preterm infants admitted to Neonatal Intensive Care Unit developing BPD as study group.
Who may be able to join
- Cohort inclusion - All term and preterm infants admitted to Neonatal (Intensive) Care Unit. Gestational Age 24-42 weeks.
Who cannot join
- Children with ciliary dyskinesia, as NO is distinguishable lower in these children.
- Children who can not cooperate to the examination.
- Children so dependant on oxygen, that the examination/measurement is not possible.
- Children with pneumothorax
- Children having a diagnosed pneumonia verified by tracheal secrete.
- Children with bigger congenital anomalies
Trial locations and contacts
2 sites in 1 country.
Denmark2 sites
Neonatal departement GN, Rigshospitalet
Copenhagen, Region H, 2200
Children´s Departement, North Zealand Hospital, Hilleroed
Hilleroed, Region H, 3400
About this study
Official title: AD-ON: The Danish Study on Tidal Neonatal Nitrogen Oxide (NO) and Vitamins A and D as Possible Predictors of BPD
Children born prematurely are of greater risk of developing chronic lung disease (Bronchopulmonary Dysplasia).
With an increase in the amount of premature children, we expect an increasing number of children with BPD.
Read more
Today we do not have many ways of predicting or treating this condition, and the children are usually in hospital for several months after birth. Many are dismissed with home oxygen. Children with BPD are typically often re-submitted to hospital with respiratory disease the first couple of years, and some of them have problems throughout childhood and into adulthood.
Other scientists have found a correlation between BPD and Chronic Obstructive Pulmonary Disease (COPD).
The condition as well as the treatment (steroids), are associated with great risk of adverse effects as Cerebral Palsy, blindness, deafness and mental retardation.
The investigators wish to find a safe way to identify the children in greater risk of developing BPD, who could therefore benefit from a more intensive treatment.An early diagnosis would increase the possibility of predicting the prognosis.
Other studies have proven a connection between both low vitamin A and D and high exhaled nitrogen oxide (NO) with lung disease.
With this trial the investigators wish to make a reference material for NO and vitamins A and D in infants admitted to the neonatal department at two hospitals in Denmark, both with and without treatment with nasal Continuous Positive Airway Pressure.
The investigators furthermore wish to describe an eventual connection between BPD and these factors by examining a large group of children on 7 specific occasions within the first two months of life and at a one year follow up.
- Conditions
- Term Delivery With Preterm Labor, Third Trimester, Term Delivery With Preterm Labor, Unspecified Trimester, Bronchopulmonary Dysplasia
- Being tested
- measurements
- Keywords
- Neonatal, Preterm, Bronchopulmonary Dysplasia, Nasal Continuous Positive airway Pressure (CPAP), Oxygen, Vitamin A, Vitamin D, Nitrogen oxide (NO), Reference material
- Medical subject headings
- Bronchopulmonary Dysplasia, Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
measurementsProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Term and preterm infants | Term and preterm infants Receives: Procedure: measurements |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tidal exhaled Nitrogen Oxide
Reference material of tidal expiratory NO in a cohort of neonates admitted to Neonatal Intensive Care Unit and Neonatal Care Unit will be made.
All children in the study will be measured on 8 occasions including a one year follow up.
Association with Bronchopulmonary Dysplasia (BPD) and the measures above will be noted.
Measured: 6-7 measures within the first 2 months of life and at 1 year of age.
Secondary outcomes (1)
Vitamin levels
Blood levels of Vitamins A (s-retinol) and D (se-25(OH)D2 and D3) will be measured at 3 preset occasions and at one year follow up, as well as maternal and cord blood at the time of birth.
Reference material will be made and association to BPD will be noted.
Measured: From birth to a one year follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2012 (estimated)
- Study startAug 2013
- Primary completionNov 2015
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Term Delivery With Preterm Labor, Third TrimesterStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hillerod Hospital, Denmark
- Sponsor type
- University, hospital or other
- Collaborators
- Copenhagen University Hospital, Rigshospitalet
- Responsible party
- Principal investigator, Birgitte Johanne Schmidt, Hillerod Hospital, Denmark
- Investigators
- Birgitte J Schmidt, MD, Principal investigator, Children´s Dep, North Zealand Hospital Hilleroed, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01722760
- Sponsor's protocol ID
- H-4-2012-091
- Status last verified
- Nov 2015
- First submitted
- 24 Oct 2012
- Last updated
- 6 Nov 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- AD-ON: The Danish Study on Tidal Neonatal Nitrogen Oxide (NO) and Vitamins A and D as Possible Predictors of BPD
- ClinicalTrials.gov ID
- NCT01722760
- Acronym / sponsor ID
- H-4-2012-091
- Conditions
- Term Delivery With Preterm Labor, Third Trimester, Term Delivery With Preterm Labor, Unspecified Trimester, Bronchopulmonary Dysplasia
- Keywords
- Neonatal, Preterm, Bronchopulmonary Dysplasia, Nasal Continuous Positive airway Pressure (CPAP), Oxygen, Vitamin A, Vitamin D, Nitrogen oxide (NO)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,500 participants (actual)
- Lead sponsor
- Hillerod Hospital, DenmarkUniversity, hospital or other
- Collaborators
- Copenhagen University Hospital, Rigshospitalet
- Study start
- Aug 2013
- Primary completion
- Nov 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 7 Nov 2012 (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.
Children born prematurely are of greater risk of developing chronic lung disease (Bronchopulmonary Dysplasia).
With an increase in the amount of premature children, we expect an increasing number of children with BPD.
Today we do not have many ways of predicting or treating this condition, and the children are usually in hospital for several months after birth. Many are dismissed with home oxygen. Children with BPD are typically often re-submitted to hospital with respiratory disease the first couple of years, and some of them have problems throughout childhood and into adulthood.
Other scientists have found a correlation between BPD and Chronic Obstructive Pulmonary Disease (COPD).
The condition as well as the treatment (steroids), are associated with great risk of adverse effects as Cerebral Palsy, blindness, deafness and mental retardation.
The investigators wish to find a safe way to identify the children in greater risk of developing BPD, who could therefore benefit from a more intensive treatment.An early diagnosis would increase the possibility of predicting the prognosis.
Other studies have proven a connection between both low vitamin A and D and high exhaled nitrogen oxide (NO) with lung disease.
With this trial the investigators wish to make a reference material for NO and vitamins A and D in infants admitted to the neonatal department at two hospitals in Denmark, both with and without treatment with nasal Continuous Positive Airway Pressure.
The investigators furthermore wish to describe an eventual connection between BPD and these factors by examining a large group of children on 7 specific occasions within the first two months of life and at a one year follow up.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Term and preterm infants | – | Procedure: measurementsTerm and preterm infants |
Who may qualify
- Ages
- Up to 2 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Term and preterm infants admitted to Neonatal Care Unit for reference material as control group. Preterm infants admitted to Neonatal Intensive Care Unit developing BPD as study group.
Key inclusion criteria (1 listed)
- Cohort inclusion - All term and preterm infants admitted to Neonatal (Intensive) Care Unit. Gestational Age 24-42 weeks.
Key exclusion criteria (6 listed)
- Children with ciliary dyskinesia, as NO is distinguishable lower in these children.
- Children who can not cooperate to the examination.
- Children so dependant on oxygen, that the examination/measurement is not possible.
- Children with pneumothorax
- Children having a diagnosed pneumonia verified by tracheal secrete.
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 |
|---|---|---|
| measurements | Procedure or surgery | Term and preterm infants |
Primary outcome
Tidal exhaled Nitrogen Oxide
Time frame: 6-7 measures within the first 2 months of life and at 1 year of age.
Reference material of tidal expiratory NO in a cohort of neonates admitted to Neonatal Intensive Care Unit and Neonatal Care Unit will be made. All children in the study will be measured on 8 occasions including a one year follow up. Association with Bronchopulmonary Dysplasia (BPD) and the measures above will be noted.
1 secondary outcome
Vitamin levels
Time frame: From birth to a one year follow up
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 6 Nov 2015.
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.
Birgitte J Schmidt, MD principal investigator
Children´s Dep, North Zealand Hospital Hilleroed, Denmark
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Term Delivery With Preterm Labor, Third Trimester and Term Delivery With Preterm Labor, Unspecified Trimester, run by Hillerod Hospital, Denmark at 2 sites in Denmark.
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 6 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 6 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Denmark. 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 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.
What does the primary outcome measure?
Tidal exhaled Nitrogen Oxide (time frame: 6-7 measures within the first 2 months of life and at 1 year of 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 6 Nov 2015.