Tidal Neonatal NO, Vitamins A and D, and Infant Lung Disease - The AD-ON Study
Information source: Hillerod Hospital, Denmark
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Term Delivery With Preterm Labor, Third Trimester; Term Delivery With Preterm Labor, Unspecified Trimester; Bronchopulmonary Dysplasia
Intervention: measurements (Procedure)
Phase: N/A
Status: Active, not recruiting
Sponsored by: Hillerod Hospital, Denmark Official(s) and/or principal investigator(s): Birgitte J Schmidt, MD, Principal Investigator, Affiliation: ChildrenĀ“s Dep, North Zealand Hospital Hilleroed, Denmark
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.
Clinical Details
Official title: AD-ON: The Danish Study on Tidal Neonatal Nitrogen Oxide (NO) and Vitamins A and D as Possible Predictors of BPD
Study design: Observational Model: Cohort, Time Perspective: Prospective
Primary outcome: Tidal exhaled Nitrogen Oxide
Secondary outcome: Vitamin levels
Eligibility
Minimum age: N/A.
Maximum age: 2 Days.
Gender(s): Both.
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
Locations and Contacts
Neonatal departement GN, Rigshospitalet, Copenhagen, Region H 2200, Denmark
ChildrenĀ“s Departement, North Zealand Hospital, Hilleroed, Hilleroed, Region H 3400, Denmark
Additional Information
Starting date: August 2013
Last updated: May 29, 2015
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