First immunization of premature infants born before 33 weeks of gestation; safe at home or is cardiorespiratory monitoring in the hospital necessary?

First immunization of premature infants born before 33 weeks of gestation; safe at home or is cardiorespiratory monitoring in the hospital necessary? - Cardiorespiratory disturbances after 1st vaccination in premature infants

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON41573

Enrollment

Registered

2013-03-05

Start date

2015-01-03

Completion date

Unknown

Last updated

2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

verstoringen van vitale functies na reguliere vaccinatie cardiorespiratory incidents post-immunization safety of immunization

Interventions

None listed

Eligibility

Age

2 Years to 11 Years

Inclusion criteria

Inclusion criteria: children born prematurely (gestational age

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
Number and characteristics of the following cardiorespiratory events: - apnea - bradycardia - cyanosis definitions - apnea = isolated respiratory pause >= 20 seconds or respiratory pause > 15 seconds combined with a heart rate = 20 seconds. - cyanosis = transcutaneous oxygensaturation 15 seconds.	—

Secondary

Measure	Time frame
- bodytemperature - local skin reaction - changed nutritional pattern - changed sleep pattern - need for analgesia	—

Countries

Netherlands

Outcome results