Tidal Neonatal NO, Vitamins A and D, and Infant Lung Dise... | NCT01722760

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

NCT01722760

Sponsor

Hillerod Hospital, Denmark

Status

Completed

Last Update Posted

Nov 6, 2015Estimated

Enrollment

1,500Actual

Phase

Not provided

Conditions

Term Delivery With Preterm Labor, Third Trimester
Term Delivery With Preterm Labor, Unspecified Trimester
Bronchopulmonary Dysplasia

Interventions

measurements

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2013

Primary Completion Date

Nov 2015Actual

Completion Date

Nov 2015Actual

First Submitted Date

Oct 24, 2012

First Submission Date that Met QC Criteria

Nov 6, 2012

First Posted Date

Nov 7, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 5, 2015

Last Update Posted Date

Nov 6, 2015Estimated

Name	Class
Rigshospitalet, Denmark	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Conditions Module

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

1,500Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Term and preterm infants		Term and preterm infants	Procedure: measurements

Interventions

Name	Type	Description	Arm Group Labels	Other Names
measurements	Procedure		Term and preterm infants

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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.

Secondary Outcomes

Measure	Description	Time Frame
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

Other Outcomes

Measure	Description	Time Frame
Bronchopulmonary Dysplasia	The incidence of BPD and the correlation the the above mentioned biomarkers.	From premature birth to a one year follow up

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

2 Days

Standard Ages

Child

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.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Birgitte J Schmidt, MD	Children´s Dep, North Zealand Hospital Hilleroed, Denmark	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Neonatal departement GN, Rigshospitalet		Copenhagen	Region H	2200	Denmark
Children´s Departement, North Zealand Hospital, Hilleroed

Condition Browse Module

MeSH Terms

ID	Term
D001997	Bronchopulmonary Dysplasia
D047928	Premature Birth

Ancestor Terms

ID	Term
D055397	Ventilator-Induced Lung Injury
D055370	Lung Injury
D008171	Lung Diseases
D012140	Respiratory Tract Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D014894	Weights and Measures

Ancestor Terms

ID	Term
D008919	Investigative Techniques

Browse Leaves

Not provided

Browse Branches

Not provided