Tidal Neonatal NO - is Bronchopulmonary Dysplasia Predictable?
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Purpose
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 submitted to hospital with respiratory disease the first couple of years, and some of the have problems throughout childhood and into adulthood.
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 carbon dioxide (CO) with lung disease.
With this trial the investigators wish to make a reference material for NO, CO, 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.
| Condition | Intervention |
|---|---|
|
Term Delivery With Preterm Labor, Third Trimester Term Delivery With Preterm Labor, Unspecified Trimester Bronchopulmonary Dysplasia |
Procedure: measurements |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Tidal Nitrogen-oxide Levels in Prematurely Born Children With and Without Continuous Positive Airway Pressure - Is Bronchopulmonary Dysplasia Predictable? |
- Tidal exhaled Nitrogen Oxide [ Time Frame: 6 measures within the first 2 months of life and at 1 year of age. ] [ Designated as safety issue: No ]
Reference material of tidal expiratory NO and CO 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 7 occasions including a one year follow up.
Association with Bronchopulmonary Dysplasia (BPD) and the measures above will be noted.
- Vitamin levels [ Time Frame: From birth to a one year follow up ] [ Designated as safety issue: No ]
Blood levels of Vitamins A (s-retinol) and D (s-1,25-(OH)2D3 and s-25(OH)D)will be measured at 3 preset occasions and at one year follow up.
Reference material will be made and association to BPD will be noted.
- Bronchopulmonary Dysplasia [ Time Frame: From premature birth to a one year follow up ] [ Designated as safety issue: No ]The incidence of BPD and the correlation the the above mentioned biomarkers.
Biospecimen Retention: Samples Without DNA
Air samples for Nitrogen oxide NO and carbonmonoxide CO Blood samples for vitamins A and D
| Estimated Enrollment: | 150 |
| Study Start Date: | November 2012 |
| Estimated Study Completion Date: | October 2015 |
| Estimated Primary Completion Date: | October 2014 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
Term and preterm infants
Term and preterm infants
|
Procedure: measurements |
Eligibility| Ages Eligible for Study: | up to 2 Days |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
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.
Inclusion Criteria:
Cohort inclusion - All term and preterm infants admitted to Neonatal Care Unit. Gestational Age 24-42 weeks.
Exclusion Criteria:
- 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
Contacts and Locations| Contact: B J Schmidt, M.D | +45 2685 3151 | Birgitte.Johanne.Schmidt@regionh.dk |
| Contact: I M Joergensen, Ass. proff. | +045 4829 4308 | Merete.Joergensen.01@regionh.dk |
| Denmark | |
| Neonatal departement GN, Rigshospitalet | Not yet recruiting |
| Copenhagen, Region H, Denmark, 2200 | |
| Contact: Birgitte J Schmidt, MD + 2685 3151 Birgitte.Johanne.Schmidt@regionh.dk | |
| Contact: Gorm Greisen, Professor +045 3545 4320 Gorm.Greisen@regionh.dk | |
| Principal Investigator: Birgitte J Schmidt, MD | |
| Children´s Departement, North Zealand Hospital, Hilleroed | Not yet recruiting |
| Hilleroed, Region H, Denmark, 3400 | |
| Contact: Birgitte J Schmidt, MD +45 2685 3151 Birgitte.Johanne.Schmidt@regionh.dk | |
| Contact: Inger M Joergensen, Ass proff. +45 4829 4308 Merete.Joergensen.01@regionh.dk | |
| Principal Investigator: Birgitte J Schmidt, MD | |
| Principal Investigator: | Birgitte J Schmidt, MD | Children´s Dep, North Zealand Hospital Hilleroed, Denmark |
More Information
No publications provided
| Responsible Party: | Birgitte Johanne Schmidt, MD, Hillerod Hospital, Denmark |
| ClinicalTrials.gov Identifier: | NCT01722760 History of Changes |
| Other Study ID Numbers: | H-4-2012-091 |
| Study First Received: | October 24, 2012 |
| Last Updated: | November 6, 2012 |
| Health Authority: | Denmark: National Board of Health |
Keywords provided by Hillerod Hospital, Denmark:
|
Neonatal Preterm Bronchopulmonary Dysplasia Nasal Continuous Positive airway Pressure (CPAP) Oxygen |
Vitamin A Vitamin D Nitrogen oxide (NO) Carbon monoxide (CO) Reference material |
Additional relevant MeSH terms:
|
Obstetric Labor, Premature Bronchopulmonary Dysplasia Hyperplasia Ventilator-Induced Lung Injury Lung Injury Lung Diseases |
Respiratory Tract Diseases Infant, Premature, Diseases Infant, Newborn, Diseases Obstetric Labor Complications Pregnancy Complications Pathologic Processes |
ClinicalTrials.gov processed this record on May 19, 2013