Tidal Neonatal NO, Vitamins A and D, and Infant Lung Disease - The AD-ON Study

Bronchopulmonary Dysplasia Clinical Trial

Official title:

AD-ON: The Danish Study on Tidal Neonatal Nitrogen Oxide (NO) and Vitamins A and D as Possible Predictors of BPD

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01722760
• Other study ID #: H-4-2012-091
• Status: Completed
• Phase: N/A
• First received: October 24, 2012
• Last updated: November 5, 2015
• Start date: August 2013
• Est. completion date: November 2015

Study information

• Verified date: November 2015
• Source: Hillerod Hospital, Denmark
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: National Board of Health
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1500
• Est. completion date: November 2015
• Est. primary completion date: November 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A to 2 Days

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Bronchopulmonary Dysplasia
• Obstetric Labor, Premature
• Premature Birth
• Term Delivery With Preterm Labor, Third Trimester
• Term Delivery With Preterm Labor, Unspecified Trimester

Intervention

Procedure:
• measurements

Locations

Country	Name	City	State
Denmark	Neonatal departement GN, Rigshospitalet	Copenhagen	Region H
Denmark	Children´s Departement, North Zealand Hospital, Hilleroed	Hilleroed	Region H

Sponsors (2)

Lead Sponsor	Collaborator
Hillerod Hospital, Denmark	Rigshospitalet, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Bronchopulmonary Dysplasia	The incidence of BPD and the correlation the the above mentioned biomarkers.	From premature birth to a one year follow up	No
Primary	Tidal exhaled Nitrogen Oxide	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.	6-7 measures within the first 2 months of life and at 1 year of age.	No
Secondary	Vitamin levels	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.	From birth to a one year follow up	No