Pacifier Use in Mechanically Ventilated Term Newborns

NCT06170957 | Unknown

• 1 other identifier: HİTİTU
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

newborn; mechanical ventilator; pacifier; physiological variables; pain; stress; cortisol level; invasive procedure (heel blood)

Outcome Measures

Primary Outcomes (6)

• Face, Legs, Activity, Cry, Consolability Pain Rating Scale

  Pain level, min= 0 point, max= 10 point, 0 points = baby is calm and pain-free Score between 1-3 = baby has mild pain Score between 4-6 = the baby has moderate pain Score between 7-10 = the baby has serious pain

  40 minutes

• Physiological Variables

  systolic-diastolic blood pressure (mmHg)

  40 minutes

• Physiological Variables

  peak heart rate (min)

  40 minutes

• Physiological Variables

  respiratory rate (min)

  40 minutes

• Physiological Variables

  oxygen saturation value (%SpO2)

  40 minutes

• Measurement of Saliva Cortisol Level in Stress Assessment

  Saliva level

  40 minutes

Study Arms (2)

Experimental group

EXPERIMENTAL

For the experimental group; A modified pacifier will be given to the newborn during the heel blood collection procedure.

Other: Modified pacifier

Control group

NO INTERVENTION

For the control group; The newborn will not be given a modified pacifier during the heel blood collection procedure.

Interventions

Modified pacifier OTHER

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.

Experimental group

Eligibility Criteria

• Age: 1 Day - 28 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Newborns at 37-42 weeks who are connected to mechanical ventilator (intubated),
• Newborns on mechanical ventilator due to respiratory distress, Orotracheally connected to a mechanical ventilator,
• Intubated,
• Intubation tube without cuff, in the range of 3.5-4 mm diameter (in the calculation of intubation tube diameter in newborns, the calculation will be based on weight).
• Mechanical ventilator mode with "Pressure control/ Pressure control- Synchronized intermittent mandatory ventilation/ Synchronized intermittent mandatory ventilation" (PC-SIMV). There are also.)
• No neurological disorder,
• The babies of the families who agreed to participate in the study will be formed.

You may not qualify if:

• With neuromuscular disease,
• Structural and congenital malformations of the respiratory tract,
• İn the CPAP mask,
• Fed with orogastric,
• The intubation tube is fixed in the middle of the newborn, not the rim.
• Mechanical ventilator settings change frequently,
• Taking neuromuscular blocking drugs,
• Receiving high-dose inotropic support (Dopamine and/or Dobutamine 10mcg/kg/hour),
• Receiving medical treatment for chronic pain,

Sponsors & Collaborators

• Hitit University: lead

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MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor Dr.

Model Details: Randomized Controlled Study

Study Record Dates

• First Submitted: September 2, 2023
• First Posted: December 14, 2023
• Study Start: January 1, 2024
• Primary Completion: October 1, 2024
• Study Completion: August 1, 2025
• Last Updated: December 14, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share