CClinicalTrials.gg
Not yet recruitingNCT06310408Updated Mar 15, 2024

Comparison Between Nasal Mask vs Nasal Prong on Pain Response in Neonate

An interventional study of nasal mask and nasal prong in Nasal Mask and Nasal Prong, sponsored by Indonesia University. Not yet recruiting. Open to participants aged 26 Weeks to 44 Weeks. Per ClinicalTrials.gov, last updated 2024-03-15.

Sponsored by Indonesia University · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Primary completion was expected by Jun 2024, 2 years 4 months ago, but the record still lists the study as not yet recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
44
Allocation
Randomized
Ages
26 Weeks to 44 Weeks
Sex
All
01

Study summary

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

Read the detailed description

To see the comparison of nasal masks and nasal prongs on the pain response of neonates, by measuring salivary cortisol levels before and after the intervention

02

Conditions studied

  • Nasal Mask
  • Nasal Prong

Keywords

  • nasal mask, nasal prong, pain response
03

In context

Lead sponsor

Indonesia University is the lead sponsor of 448 studies on the registry; 56 are open to participants now.

Of its 6 completed or terminated interventional studies of FDA-regulated products, 1 (17%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
26 Weeks to 44 Weeks
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Newborn with espiratory distress and need noninvasive respiratory support

Exclusion criteria

Exclusion Criteria:

  • Syok, multiple congenital anomaly
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
44 participants (estimated)

Study arms

  • Experimental
    nasal mask

    Give noninvasif respiratory support with interface nasal mask

    Device: nasal mask

  • Active comparator
    nasal prong

    Give noninvasif respiratory support with interface nasal prong

    Device: nasal prong

Interventions

  • Devicenasal mask

    Give interface nasal mask

  • Devicenasal prong

    give interface nasal prong

06

What researchers measure

Primary outcomes

  1. pain response

    kortisol saliva level

    Time frame: 20 weeks

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: Yes

Supporting information: Study protocol

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 15, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06310408
Lead sponsor
Indonesia University
Responsible party
Besse Sarmila (dr, Hasanuddin University) — Principal investigator
First posted
Mar 15, 2024
Start date
Mar 15, 2024 (estimated)
Primary completion
Jun 1, 2024 (estimated)
Completion
Jun 1, 2024 (estimated)
Last update
Mar 15, 2024

Study contacts

Besse Sarmila
Contact
bessesarmila96@gmail.com
081342540966
Praja utama
Contact
prajautama.84@gmail.com
081242368292

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Mar 2024. You cannot join it, but the record below documents what was studied.

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