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

Sponsor

Hillerod Hospital, Denmark (Other)

Overall Status

Completed

CT.gov ID

NCT01722760

Collaborator

Rigshospitalet, Denmark (Other)

1,500

Enrollment

Locations

Duration (Months)

750

Patients Per Site

27.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Term Delivery With Preterm Labor, Third Trimester Term Delivery With Preterm Labor, Unspecified Trimester Bronchopulmonary Dysplasia	Procedure: measurements

Study Design

Study Type:

Observational

Actual Enrollment :

1500 participants

Observational Model:

Cohort

Time Perspective:

Prospective

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 :

Aug 1, 2013

Actual Primary Completion Date :

Nov 1, 2015

Actual Study Completion Date :

Nov 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Term and preterm infants Term and preterm infants	Procedure: measurements

Arm

Intervention/Treatment

Term and preterm infants

Procedure: measurements

Outcome Measures

Primary Outcome Measures

Tidal exhaled Nitrogen Oxide [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.

Secondary Outcome Measures

Vitamin levels [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.

Other Outcome Measures

Bronchopulmonary Dysplasia [From premature birth to a one year follow up]
The incidence of BPD and the correlation the the above mentioned biomarkers.

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A to 2 Days

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Cohort inclusion - All term and preterm infants admitted to Neonatal (Intensive) Care Unit. Gestational Age 24-42 weeks.

Exclusion Criteria:

Children with ciliary dyskinesia, as NO is distinguishable lower in these children.
Children who can not cooperate to the examination.
Children so dependant on oxygen, that the examination/measurement is not possible.
Children with pneumothorax
Children having a diagnosed pneumonia verified by tracheal secrete.
Children with bigger congenital anomalies

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Neonatal departement GN, Rigshospitalet	Copenhagen	Region H	Denmark	2200
2	Children´s Departement, North Zealand Hospital, Hilleroed	Hilleroed	Region H	Denmark	3400