NCT01361360

Brief Summary

In the US, every year approximately 30,000 infants are born very prematurely, with birth weight less than 1000 grams. These infants usually require ventilators to help them breath normally during the first few weeks of life. Although the ventilator is lifesaving, it can also injure the very fragile lungs of these infants. Thus, a ventilation strategy, called permissive hypercapnia (high carbon dioxide), is widely used to prevent lung injury. Importantly, there is new research showing that high carbon dioxide may cause brain injury. In our proposed research, we will use magnetic resonance imaging methods to evaluate the brain in 40 very premature infants at term-equivalent age (Half of them had permissive hypercapnia ventilation, the other half did not) to see if permissive hypercapnia has adverse effect on brain development.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started May 2011

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2011

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

May 25, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 26, 2011

Completed
5.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2016

Completed
Last Updated

July 25, 2017

Status Verified

July 1, 2017

Enrollment Period

5.4 years

First QC Date

May 25, 2011

Last Update Submit

July 24, 2017

Conditions

Premature Birth

Outcome Measures

Primary Outcomes (1)

  • MRI

    0

Study Arms (2)

control

hypercapnia

Eligibility Criteria

Age3 Months - 5 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

Premature infants with birth weight 401-1000 g (gestational age \< 30 weeks)

You may qualify if:

  • Premature infants with birth weight 401-1000 g

You may not qualify if:

  • Those with complex congenital anomalies, central nervous system malformations, chromosomal abnormalities, or hydrops fetalis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Arkansas Children's Hospital

Little Rock, Arkansas, 72211, United States

Location

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 25, 2011

First Posted

May 26, 2011

Study Start

May 1, 2011

Primary Completion

October 1, 2016

Study Completion

October 1, 2016

Last Updated

July 25, 2017

Record last verified: 2017-07

Locations

US(1)