Brief Title
Tidal Neonatal NO, Vitamins A and D, and Infant Lung Disease - The AD-ON Study
Official Title
AD-ON: The Danish Study on Tidal Neonatal Nitrogen Oxide (NO) and Vitamins A and D as Possible Predictors of BPD
Brief 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. 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 Type
Observational
Primary Outcome
Tidal exhaled Nitrogen Oxide
Secondary Outcome
Vitamin levels
Condition
Term Delivery With Preterm Labor, Third Trimester
Intervention
measurements
Study Arms / Comparison Groups
Term and preterm infants
Description: Term and preterm infants
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Procedure
Estimated Enrollment
1500
Start Date
August 2013
Completion Date
November 2015
Primary Completion Date
November 2015
Eligibility Criteria
Inclusion Criteria: Cohort inclusion - All term and preterm infants admitted to Neonatal (Intensive) Care Unit. Gestational Age 24-42 weeks. Exclusion Criteria: 1. Children with ciliary dyskinesia, as NO is distinguishable lower in these children. 2. Children who can not cooperate to the examination. 3. Children so dependant on oxygen, that the examination/measurement is not possible. 4. Children with pneumothorax 5. Children having a diagnosed pneumonia verified by tracheal secrete. 6. Children with bigger congenital anomalies
Gender
All
Ages
N/A - 2 Days
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Contacts
Birgitte J Schmidt, MD, ,
Location Countries
Denmark
Location Countries
Denmark
Administrative Informations
NCT ID
NCT01722760
Organization ID
H-4-2012-091
Responsible Party
Principal Investigator
Study Sponsor
Hillerod Hospital, Denmark
Collaborators
Rigshospitalet, Denmark
Study Sponsor
Birgitte J Schmidt, MD, Principal Investigator, Children´s Dep, North Zealand Hospital Hilleroed, Denmark
Verification Date
November 2015