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

NCT ID: NCT06310408

Last Updated: 2024-03-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-15

Study Completion Date

2024-06-01

Brief Summary

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

Detailed Description

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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

Conditions

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Nasal Mask Nasal Prong

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

1 group give nasal mask

1 group give nasal prong
Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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nasal mask

Give noninvasif respiratory support with interface nasal mask

Group Type EXPERIMENTAL

nasal mask

Intervention Type DEVICE

Give interface nasal mask

nasal prong

Give noninvasif respiratory support with interface nasal prong

Group Type ACTIVE_COMPARATOR

nasal prong

Intervention Type DEVICE

give interface nasal prong

Interventions

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nasal mask

Give interface nasal mask

Intervention Type DEVICE

nasal prong

give interface nasal prong

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Newborn with espiratory distress and need noninvasive respiratory support

Exclusion Criteria

* Syok, multiple congenital anomaly
Minimum Eligible Age

26 Weeks

Maximum Eligible Age

44 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Indonesia University

OTHER

Sponsor Role lead

Responsible Party

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Besse Sarmila

dr

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Besse Sarmila

Role: CONTACT

081342540966

Praja utama

Role: CONTACT

081242368292

Other Identifiers

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0214022024

Identifier Type: -

Identifier Source: org_study_id

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