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Ultrasound of the vocal cords in preterm infants during neonatal transition at birth; an observational study

Ultrasound of the vocal cords in preterm infants during neonatal transition at birth; an observational study - VOCAL

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON51906
Enrollment
20
Registered
2021-08-02
Start date
2021-09-30
Completion date
Unknown
Last updated
2025-08-18

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

Conditions

active larynx closure Vocal cords movement

Interventions

None listed

Sponsors

Leids Universitair Medisch Centrum
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Infants are eligable when born prematurely (24 0/7 to 29 6/7 weeks of gestation. Written parental consent for enrollment in the study will be obtained.

Exclusion criteria

Exclusion criteria: Exclusion criteria are significant congenital malformations impeding ultrasound probe positioning or infants requiring intubation and/or cardiac resuscitation. Also, patients will be excluded if they are enrolled in the ABC3 study and are enrolled in the Concord group [Protocol nr. NL67770.058.18].

Design outcomes

Primary

MeasureTime frame
The percentage of time the vocal cords are closed and open during apnea, mask ventilation and spontaneous breathing.

Secondary

MeasureTime frame
The position of the vocal cords will be correlated with respiratory function parameters (gas flow, tidal volume, inflation pressure), which are recorded as standard care.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)