Tidal Neonatal NO, Vitamins A and D, and Infant Lung Disease - The AD-ON Study
|ClinicalTrials.gov Identifier: NCT01722760|
Recruitment Status : Completed
First Posted : November 7, 2012
Last Update Posted : November 6, 2015
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.
|Condition or disease||Intervention/treatment|
|Term Delivery With Preterm Labor, Third Trimester Term Delivery With Preterm Labor, Unspecified Trimester Bronchopulmonary Dysplasia||Procedure: measurements|
|Study Type :||Observational|
|Actual Enrollment :||1500 participants|
|Official Title:||AD-ON: The Danish Study on Tidal Neonatal Nitrogen Oxide (NO) and Vitamins A and D as Possible Predictors of BPD|
|Study Start Date :||August 2013|
|Actual Primary Completion Date :||November 2015|
|Actual Study Completion Date :||November 2015|
Term and preterm infants
Term and preterm infants
- 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.
- Vitamin levels [ Time Frame: From birth to a one year follow up ]
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.
- Bronchopulmonary Dysplasia [ Time Frame: From premature birth to a one year follow up ]The incidence of BPD and the correlation the the above mentioned biomarkers.
Biospecimen Retention: Samples Without DNA
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01722760
|Neonatal departement GN, Rigshospitalet|
|Copenhagen, Region H, Denmark, 2200|
|Children´s Departement, North Zealand Hospital, Hilleroed|
|Hilleroed, Region H, Denmark, 3400|
|Principal Investigator:||Birgitte J Schmidt, MD||Children´s Dep, North Zealand Hospital Hilleroed, Denmark|