Clinical trial NCT01722760: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
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)
Reference material
Lead sponsor: Hillerod Hospital, Denmark
Sponsor class: OTHER
Collaborators: name: Rigshospitalet, Denmark
First posted: 2012-11-07
Enrollment: 1500
Sex: ALL
Maximum age (years): 2
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

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.


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

Primary outcomes:
measure: Tidal exhaled Nitrogen Oxide
timeFrame: 6-7 measures within the first 2 months of life and at 1 year of age.
Secondary outcomes:
measure: Vitamin levels
timeFrame: From birth to a one year follow up
Other outcomes:
measure: Bronchopulmonary Dysplasia
timeFrame: From premature birth to a one year follow up
Locations:
city: Copenhagen
country: Denmark
facility: Neonatal departement GN, Rigshospitalet
state: Region H
city: Hilleroed
country: Denmark
facility: Children´s Departement, North Zealand Hospital, Hilleroed
state: Region H
Study officials:
affiliation: Children´s Dep, North Zealand Hospital Hilleroed, Denmark
name: Birgitte J Schmidt, MD
role: PRINCIPAL_INVESTIGATOR
References: