NCT06310408

Brief Summary

to determine the comparison of nasal masks and nasal prongs on the pain response of neonate

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
44

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2024

Shorter than P25 for not_applicable

Status
not yet recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 7, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 15, 2024

Completed
Same day until next milestone

Study Start

First participant enrolled

March 15, 2024

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2024

Completed
Last Updated

March 15, 2024

Status Verified

March 1, 2024

Enrollment Period

3 months

First QC Date

March 7, 2024

Last Update Submit

March 7, 2024

Conditions

Nasal MaskNasal Prong

Keywords

nasal mask, nasal prong, pain response

Outcome Measures

Primary Outcomes (1)

  • pain response

    kortisol saliva level

    20 weeks

Study Arms (2)

nasal mask

EXPERIMENTAL

Give noninvasif respiratory support with interface nasal mask

Device: nasal mask

nasal prong

ACTIVE COMPARATOR

Give noninvasif respiratory support with interface nasal prong

Device: nasal prong

Interventions

nasal maskDEVICE

Give interface nasal mask

nasal mask
nasal prongDEVICE

give interface nasal prong

nasal prong

Eligibility Criteria

Age26 Weeks - 44 Weeks
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Newborn with espiratory distress and need noninvasive respiratory support

You may not qualify if:

  • Syok, multiple congenital anomaly

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Central Study Contacts

Besse Sarmila

CONTACT

081342540966bessesarmila96@gmail.com

Praja utama

CONTACT

081242368292prajautama.84@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: 1 group give nasal mask 1 group give nasal prong
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
dr

Study Record Dates

First Submitted

March 7, 2024

First Posted

March 15, 2024

Study Start

March 15, 2024

Primary Completion

June 1, 2024

Study Completion

June 1, 2024

Last Updated

March 15, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL
Time Frame
i year