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Pacifier Use in Mechanically Ventilated Term Newborns

NCT06170957 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2023-12-14

No results posted yet for this study

Summary

Newborns on mechanical ventilator; It is stated that they need to calm and soothe themselves, their coordination in sucking and swallowing reflexes is not good, they have aspiration risks, their weight gain and discharge are prolonged, and physiological stability is impaired. It is suggested that pacifiers can be used to reduce stress levels in these newborns. It has been observed that sterile gloves are used as pacifiers because the pacifier shields available in the market are not suitable for the intubation tube to calm the babies in the NICU. In order to reduce the stress level in newborns, developed in the light of this information, pacifier shields ergonomically suitable for intubation tube are designed. In this context, a modified pacifier shield was produced using a 3D printer from polypropylene (PP), a biocompatible polymer. It is aimed to examine the effects of using a modified pacifier on pain, physiological variables and stress level during heel blood collection in newborns who are connected to mechanical ventilator due to respiratory distress, considering that it would be more beneficial for newborns to adapt and use a model closest to the pacifier they will use in the future with the use of this modified pacifier.

Conditions

  • Pacifier

Interventions

OTHER

Modified pacifier

In this project, a pacifier produced from a modified pacifier shield made of polypropylene (PP), a biocompatible polymer, which is made suitable for intubation tube in newborns connected to mechanical ventilator, will be used in the light of literature information. No study on the modification of the pacifier shield has been found in the literature, and a utility model application (file number 2020/03477 dated 06 March 2020) was made for this pacifier shield, which is planned to be modified, and the utility model application was accepted on 04.02.2022. In the application of heel blood collection to newborns, a) before the procedure (20 minutes before), b) immediately before the procedure (20. minutes), c) during the procedure (between the 20th and 40th minutes), and d) 20 minutes after the procedure (40 minutes) will be evaluated once for each application, a total of four times.

Sponsors & Collaborators

  • Hitit University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
1 Day
Max Age
28 Days
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-01-01
Primary Completion
2024-10-01
Completion
2025-08-01

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06170957 on ClinicalTrials.gov