Oxygen Saturation and Caffeine Post-Discharge

Prematurity Clinical Trial

— OCPDPS  

Official title:

Does the Use of Caffeine Post Discharge Normalize the Respiratory Patterns in Infants Born Earlier Than 35 Weeks? A Cohort Study

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02386046
• Other study ID #: REB14-0175
• Status: Terminated
• Start date: February 2015
• Est. completion date: October 31, 2017

Study information

• Verified date: May 2017
• Source: University of Calgary
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This study aims to determine normative values of oxygen saturation in late preterm infants, and evaluate the frequency of hypoxic events in infants requiring caffeine at discharge and those not requiring it.

Description:

Apnea of prematurity is a common morbidity among premature infants. Recent studies suggest an association between apnea and neurodevelopmental impairment. Our objectives are to determine normative values of oxygen saturation in late preterm infants -reference group. In infants born 28-35 weeks requiring caffeine- study group and infants born 28-35 weeks not requiring caffeine-control group we will be evaluating the frequency of hypoxic events. Recruitment time: February 2015 until December 2016.

After consent a pulse oxymeter will be placed on the infant's right wrist. For those infants that will receive caffeine prior to discharge, this medication will be instituted after 12 hours of the initiation of the study and continue for the remaining of the hospitalization. For all other infants, the pulse oxymeter will be done continuously until discharge. After discharge, the recording will be done at home once a week until 46 weeks corrected age in the three groups.

All the data will be reviewed by a blind observer to the groups from which that data comes. The data will be analyzed by a statistician.

Normative values will be developed on the reference group until 46 weeks post conceptional age.

Any medical problems encounter by the patients while on the study or in the following 6 months will be recorded to establish the safety of caffeine use at home and its discontinuation at 44 weeks post conceptional age.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 144
• Est. completion date: October 31, 2017
• Est. primary completion date: October 31, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 26 Weeks to 46 Weeks

Eligibility

Inclusion Criteria of infants admitted to NICU:

1. Gestational age at birth of < or = 35 weeks

2. Families of infants that live in Calgary

3. Infants discharged home from PLC or South Health Campus (SHC)

4. Decision of treating team to start caffeine

5. No episodes of clinically significant apnea for a period of 3 to 5 days prior to discharge

6. Infant has access to reliable post-discharge follow up

Exclusion Criteria of all infants:

1. Active serious medical conditions other than apnea (Congenital Heart Disease (CHD), Chronic Lung Disease (CLD), symptomatic anemia).

2. Congenital disorders like Trisomies, genetic syndromes, midline defects, metabolic disorders.

Related Conditions & MeSH terms

• Prematurity

Intervention

Other:
• Pulse oxymeter measurements
Pulse oxymeter measurements done at the hospital and upon discharge, weekly until 46 weeks postconceptional age

Locations

Country	Name	City	State
Canada	Peter Logheed Center	Calgary	Alberta

Sponsors (1)

Lead Sponsor	Collaborator
University of Calgary

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pattern of Oxygen saturation	Measurements at hospital and weekly after discharge	Up to 46 weeks postconceptional age