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

NCT06639581 | Completed DMC

• 1 other identifier: 210406008
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

preterm; hypoxia; medical device

Outcome Measures

Primary Outcomes (2)

• Comparison of mean of Tidal Volume(TV) between the doses of dorsal mechanical stimuli

  repeated measures ANOVA for mean of Tidal Volume ( ml/kg)

  1 minute for each intervention ( dose)

• Comparison of mean of Minute Ventilation (MV) between the doses of dorsal mechanical stimuli

  repeated measures ANOVA for mean of MV ( ml/kg/ min)

  1 minute for each intervention ( dose)

Secondary Outcomes (3)

• Comparison of mean of Respiratory Rate (RR)between the doses of dorsal mechanical stimuli

  1 minute for each intervention ( dose)

• Comparison of mean of Cardiac Rate (CR)between the doses of dorsal mechanical stimuli

  1 minute for each intervention ( dose)

• Comparison of mean of percent of oxygen saturation (Sats) between the doses of dorsal mechanical stimuli

  1 minute for each intervention ( dose)

Other Outcomes (2)

• Analyss of pattern of respiratory drive between the doses of dorsal mechanical stimuli

  1 minute for each intervention ( dose)

• Risk manangement

  45-60 minutes each patient

Study Arms (4)

3mm lifting stimulus

ACTIVE COMPARATOR

Respiratory volume measures, vital signs and respiratory mechanics will be evaluated in 10 healthy preterm, by dorsal stimulation causing a displacement of 3 mm , performed by 2 operators .

Device: 20 per minute stimulus; Device: 30 per minute stimulus; Device: 40 per minute stimulus

5mm lifting stimulus

ACTIVE COMPARATOR

Respiratory volume measures, vital signs and respiratory mechanics will be evaluated in 10 healthy preterm, by dorsal stimulation causing a displacement of 5 mm , performed by 2 operators .

Device: 20 per minute stimulus; Device: 30 per minute stimulus; Device: 40 per minute stimulus

8mm lifting stimulus

ACTIVE COMPARATOR

Respiratory volume measures, vital signs and respiratory mechanics will be evaluated in 10 healthy preterm, by dorsal stimulation causing a displacement of 8 mm , performed by 2 operators .

Device: 20 per minute stimulus; Device: 30 per minute stimulus; Device: 40 per minute stimulus

Basal

NO INTERVENTION

Respiratory volume measures, vital signs and respiratory mechanics will be evaluated in 10 healthy preterm basal- without stimulation- performed by 2 operators .

Interventions

20 per minute stimulus DEVICE

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

3mm lifting stimulus; 5mm lifting stimulus; 8mm lifting stimulus

30 per minute stimulus DEVICE

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

3mm lifting stimulus; 5mm lifting stimulus; 8mm lifting stimulus

40 per minute stimulus DEVICE

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

3mm lifting stimulus; 5mm lifting stimulus; 8mm lifting stimulus

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• Pontificia Universidad Catolica de Chile: lead

Study Sites (1)

Puc, Nicu

Santiago, Santiago Metropolitan, 833-0024, Chile

Location

MeSH Terms

Conditions

Apnea; Premature Birth; Hypoxia

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Paulina A Toso, MD

  Pontificia Universidad Catolica de Chile

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: All the data is going to be registered by Rec Trial Software, anonimize and blind to everybody
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Model Details: A baseline evaluation will be carried out and with the 9 doses of dorsal stimulation resulting from the combination of displacements of 3-5 -8 mm and 20-30-40 cycles per minute, randomized and performed by 2 operators each.

Study Record Dates

• First Submitted: September 29, 2022
• First Posted: October 15, 2024
• Study Start: October 10, 2022
• Primary Completion: March 31, 2023
• Study Completion: January 31, 2024
• Last Updated: October 15, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

CL (1)