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Evaluation of Nasal Protectors used in the prevention of Nasal injury in premature infants submitted non-invasive ventilation

Comparative analysis between Hydrocholid and Silicone Gel in the prevention of Nasal injury in pre-term newborns submitted to non-invasive mechanical ventilation

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-73xvmg
Enrollment
Unknown
Registered
2018-02-23
Start date
2015-05-01
Completion date
Unknown
Last updated
2025-10-27

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

Conditions

Infant

Interventions

Experimental group: 11 preterm newborns undergoing non-invasive ventilation will receive nasal protection with hydrocolloid, columella and nasal septum until medical suspension of this ventilatory sup
Device
E07.101.074
D02.715.650.700.755

Sponsors

Universidade Tecnológica Federal do Paraná
Lead Sponsor
Hospital Infantil Waldemar Monastier
Collaborator

Eligibility

Age
No minimum to 37 Weeks

Inclusion criteria

Inclusion criteria: Preterm newborn of both genders. Preterm newborn without distinction of ethnicity. Preterm newborn without distinction of class or social group. Preterm newborn with gestational age of less than 37 weeks were submitted to non-invasive ventilation through binasal prongs as initial ventilatory support or as weaning for a minimum of 24 hours. Preterm newborn that the parents and / or guardians sign the Informed Consent Term.

Exclusion criteria

Exclusion criteria: Term neonates. Newborns with nasal deformities. Newborns on non-invasive ventilation for a period of less than 24 hours.

Design outcomes

Primary

MeasureTime frame
Expected outcome 1. Prevention of nasal lesion with the use of hydrocolloid, verified by daily clinical inspection of the nostrils, from the incidence of 0% nasal lesion, comparing the pre and post intervention measurements.;Outcome found 1. Occurrence of nasal lesion even with the preventive use of hydrocolloid, verified through daily clinical inspection, based on the incidence of nasal lesion of 36.36%, comparing the pre and post intervention measurements.;Expected outcome 2. Prevention of nasal lesions with the use of thick silicone gel, verified through daily clinical inspection of the nostrils, from the incidence of nasal lesion of 0%, comparing the pre and post intervention measurements.;Outcome found 2. Occurrence of nasal lesion even with the preventive use of thick silicone gel, verified through daily clinical inspection, from the incidence of nasal lesion of 81.81%, comparing the pre and post intervention measurements.;Expected outcome 3. Prevention of nasal lesion with the use of thin silicone gel, verified by daily clinical inspection of the nostrils, from the incidence of 0% nasal lesion, comparing the pre and post intervention measurements.;Outcome found 3. Occurrence of nasal lesion even with the preventive use of thin silicone gel, verified through daily clinical inspection, based on the incidence of nasal lesion of 72.72%, comparing the pre and post intervention measurements.

Secondary

MeasureTime frame
Expected outcome 1. Non-detachment of the hydrocolloid, verified by daily clinical inspection of the nostrils, from the mean change in protection of 0.00 times during the intervention period.;Outcome found 1. No hydrocolloid detachment, verified by daily clinical inspection of the nostrils, from the mean change of 0.00 times during the intervention period.;Expected outcome 2. Non-detachment of the thick silicone gel, verified by means of the daily clinical inspection of the nostrils, from the average protection change of 0.00 times during the intervention period.;Outcome found 2. Detachment of the thick silicone gel, verified through daily clinical inspection of the nostrils, from the mean change of 3.22 times during the intervention period.;Expected outcome 3. Non-detachment of the thin silicone gel, verified by means of daily clinical inspection of the nostrils, from the mean change of protection of 0.00 times during the intervention period.;Outcome found 3. Detachment of the thin silicone gel, verified through daily clinical inspection of the nostrils, from the mean change of 1.50 times during the intervention period.

Countries

Brazil

Contacts

Public ContactDébora Ribeiro

Debora de fátima camillo ribeiro

deborafcamillo@gmail.com+55-41-992197919

Outcome results

None listed

Source: REBEC (via WHO ICTRP)