NCT04584814

Brief Summary

Pilot study of 10 preterm, who are going to be randomly placed to 3 phases : 2 hour of basal observation of respiratory rate, heart rate, saturation, NIPS and aEEG recording, 2 hours with a 20cycles/minute with "scare ventilator", and 2 hours of 40 cycles/minute with "scare ventilator"

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2020

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

August 21, 2020

Completed
2 months until next milestone

First Posted

Study publicly available on registry

October 14, 2020

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2021

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2022

Completed
Last Updated

September 21, 2022

Status Verified

March 1, 2022

Enrollment Period

1.7 years

First QC Date

August 21, 2020

Last Update Submit

September 16, 2022

Conditions

Apnea of NewbornPreterm Labor

Keywords

respiratory ratescare ventilatorsleep wake cycle

Outcome Measures

Primary Outcomes (1)

  • Change of respiratory Synchronicity with the scare ventilator between 20 and 40 cycles per minute (cpm)

    % of time were respiratory rate is synchronised with the scare ventilator input, two tales of statistical differences, at 20 and 40 cycles per minute (cpm)

    ten minutes after each intervention starts and every ten minutes for 2 hours straight

Secondary Outcomes (10)

  • Change from baseline newborn HR using the scare ventilator at 20 cpm

    pre-intervention, ten minutes after intervention starts and every ten minutes for 2 hours straight

  • Change from baseline newborn HR using the scare ventilator at 40 cpm

    pre-intervention, ten minutes after intervention starts and every ten minutes for 2 hours straight

  • Change from baseline on Sleep-wake cycles (SWC) using the scare ventilator at 20 cpm

    pre-intervention, ten minutes after intervention starts and every ten minutes for 2 hours straight

  • Change from baseline on Sleep-wake cycles (SWC) using the scare ventilator at 40 cpm

    pre-intervention, ten minutes after intervention starts and every ten minutes for 2 hours straight

  • Change from baseline on Discomfort scale using the scare ventilator at 20 cpm

    pre-intervention, ten minutes after intervention starts every ten minutes for 2 hours straight

  • +5 more secondary outcomes

Study Arms (1)

Babies born Preterm

EXPERIMENTAL

Preterm babies, healthy at the time of the study, free of neonatal diseases and/or sequelae or malformations or genetic diseases. They were random assigned to two-hours blocks of basal, and dorsal stimulation protocol at 20 or 40 times per minute, each.

Device: No interventionDevice: scare ventilator at 20Device: scare ventilator at 40

Interventions

No interventionDEVICE

Basal analysis

Babies born Preterm
scare ventilator at 20DEVICE

To set scare ventilator by 20 cycles per minute

Babies born Preterm
scare ventilator at 40DEVICE

To set scare ventilator by 40 cycles per minute

Babies born Preterm

Eligibility Criteria

Age1 Day - 1 Month
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • hospitalized healthy preterm babies,
  • weighing more than 1500g at the time of the study

You may not qualify if:

  • babies receiving any respiratory support
  • carrier of any mayor malformation or genetic condition

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Puc, Nicu

Santiago, Santiago Metropolitan, 833-0024, Chile

Location

MeSH Terms

Conditions

Obstetric Labor, Premature

Condition Hierarchy (Ancestors)

Obstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Officials

  • Paulina Toso, MD

    Pontificia Universidad Catolica de Chile

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Model Details: 10 preterms are going to be put on random measures in 2 hours blocks of, no intervention 2 hours of scare ventilator settled at 20 cycles per minute, and 2 hours of scare ventilator at 40cycles per minute
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 21, 2020

First Posted

October 14, 2020

Study Start

March 1, 2020

Primary Completion

October 31, 2021

Study Completion

March 1, 2022

Last Updated

September 21, 2022

Record last verified: 2022-03

Locations

CL(1)