First immunization of premature infants born before 33 weeks of gestation; safe at home or is cardiorespiratory monitoring in the hospital necessary?
Completed
- Conditions
- verstoringen van vitale functies na reguliere vaccinatiecardiorespiratory incidents post-immunizationsafety of immunization
- Registration Number
- NL-OMON41573
- Lead Sponsor
- Medisch Centrum Alkmaar
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 50
Inclusion Criteria
children born prematurely (gestational age <33 wks)
discharged from the hospital in clinically stable condition at the age suitable for administration of
1st DaKTP-Hib-HepB-Pneu immunization (=postnatal age of 2 months).
Exclusion Criteria
No approval of parent.
Need for respiratory support or tubefeeding at home.
Any known congenital or acquired medical condition potentially affecting cardiorespiratory stability.
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Number and characteristics of the following cardiorespiratory events:<br /><br>- apnea<br /><br>- bradycardia<br /><br>- cyanosis<br /><br><br /><br>definitions<br /><br>- apnea = isolated respiratory pause >= 20 seconds or respiratory pause > 15<br /><br>seconds combined with a heart rate < 80 beats/minute<br /><br>during at least 5 seconds.<br /><br>- bradycardia = hearts rate < 80 beats/minute during at least >= 20 seconds.<br /><br>- cyanosis = transcutaneous oxygensaturation < 86% during > 15 seconds.</p><br>
- Secondary Outcome Measures
Name Time Method <p>- bodytemperature<br /><br>- local skin reaction<br /><br>- changed nutritional pattern<br /><br>- changed sleep pattern<br /><br>- need for analgesia</p><br>