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Pilot Study to Evaluate Doses of Mechanical Stimulus on the Effectiveness of Preterm Breathing

NCT06639581 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2024-10-15

No results posted yet for this study

Summary

The goal of this clinical trial is to compare, in healthy preterm babies, 9 doses of dorsal mechanical stimuli, in order to answer:

* if there is a dose of dorsal mechanical stimuli that improves the basal respiration.

Participants will be stimulated through a cotton shirt for one minute with each dose, while respiratory measures will be taken through a nasobuccal mask, slightly tightened by the investigator staff. All time, babies are going to be monitored and assessing that they are comfortable.

Conditions

  • Apnea of Prematurity
  • Intermittent Hypoxia

Interventions

DEVICE

20 per minute stimulus

crossover randomized mechanical dorsal stimuli -for one minute each- at 20-rates per minute

DEVICE

30 per minute stimulus

crossover randomized mechanical dorsal stimuli -for one minute each- at 30 rates per minute

DEVICE

40 per minute stimulus

crossover randomized mechanical dorsal stimuli -for one minute each- at 40 rates per minute

Sponsors & Collaborators

  • Pontificia Universidad Catolica de Chile

    lead OTHER

Principal Investigators

  • Paulina A Toso, MD · Pontificia Universidad Catolica de Chile

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-10-10
Primary Completion
2023-03-31
Completion
2024-01-31

Countries

  • Chile

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06639581 on ClinicalTrials.gov