Evaluation of Cerebral Oxygenation Results in Premature Infant

NCT04725435 | Completed

• 1 other identifier: 2021/42
• Study Type: interventional
• Target: 106
• Locations: 1 country
• Sites: 1

Brief Summary

The general purpose of this project is; Evaluation of cerebral oxygenation results in premature infants. These results will be evaluated in two different applications. The first practice and the first sub-aim of the study is to determine the effect of kangaroo care on cerebral oxygenation (rSO2) in premature infants. The second application and purpose is to determine the effect of giving the infant the facilitated tucking position by hand and the nesting bed on the cerebral oxygenation (rSO2) of the infant during the heel blood collection process. The study will be conducted between December 2020 and December 2021 at Level III NICU at the Medical Faculty Hospital in Konya.

Conditions

Cerebral Oxygenation; Premature; Kangaroo Care; Facilitated Tucking

Keywords

cerebral oxygenation; premature; kangaroo care; facilitated tucking

Outcome Measures

Primary Outcomes (5)

• The first sub-purpose Outcome: rSO2 level

  Defines the change of rSO2 level. The NIRS monitor (COVIDEN Operations Manual INVOS® System, Model 5100C) was used to monitor rSO2 levels. The normal range of the rSO2 measured by the device was between 55% and 85%.

  Change from baseline and 70 min

• The first sub-purpose Outcome: physiological parameters of the premature infant- heart rate (min).

  Defines the change of heart rate (min) level.Philips IntelliVue MP40 device was used to monitor respiratory rate. Philips IntelliVue MP40 device was used to monitor heart rate (min).

  Change from baseline and 70 min

• The first sub-purpose Outcome: physiological parameters of the premature infant- SpO2 level

  Defines the change of SpO2 level.

  Change from baseline and 70 min

• The first sub-purpose Outcome: Neonates COMFORTneo scale

  The COMFORTneo scale is a Likert-type scale consisting of seven parameters: alertness, calmness/agitation, respiratory response, crying, body movements, facial tension, and muscle tonus. The items are rated between 0 and 10, and the score that can be obtained from the scale ranges between 6 and 30. A score of 4-6 indicates moderate pain and distress and that of 7-10 indicates severe pain and distress.

  Change from baseline and 70 min

• The first sub-purpose Outcome: physiological parameters of the premature infant-respiratory rate (min)

  Defines the change of respiratory rate (min) level.

  Change from baseline and 70 min

Secondary Outcomes (6)

• The second sub-purpose Outcome: Premature Infant Pain Profile Scale-Revised (PIPP-R)

  Change from baseline and 70 min

• The second sub-purpose Outcome:Neonates The COMFORTneo Scale

  Change from baseline and 70 min

• The second sub-purpose Outcome: physiological parameters of the premature infant- respiratory rate

  Change from baseline and 70 min

• The second sub-purpose Outcome: physiological parameters of the premature infant- heart rate (min)

  Change from baseline and 70 min

• The second sub-purpose Outcome: physiological parameters of the premature infant- oxygen saturation (%SpO2)

  Change from baseline and 70 min

Study Arms (2)

Kangaroo care

EXPERIMENTAL

No Intervention: Standard care The control group will be followed by infants using nesting in the incubator. It will be followed for 60 minutes without any action or application. Experimental: Kangaroo care The mother kangaroo will care for at least 60 minutes.

Behavioral: Kangaroo care

Facilitated tucking position

EXPERIMENTAL

No Intervention: Standard care In the Control Group, the heel stick procedure will be performed in the infants own bed as in the clinical routine. Experimental 1: Manual Facilitated Tucking Position, infants will be given a manual facilitated tucking position during the heel stick procedure. Experimental 2: Facilitated Tucking Position, with the Nesting Bed (Tortoise Neo Bed), the facilitated tucking position will be given by the clinic nurse with the nesting bed during the heel stick collection procedure.

Behavioral: Facilitated Tucking Position

Interventions

Kangaroo care BEHAVIORAL

Experimental: Kangaroo care The mother kangaroo will care for at least 60 minutes.

Kangaroo care

Facilitated Tucking Position BEHAVIORAL

Experimental 1: Manual Facilitated Tucking Position, infants will be given a manual facilitated tucking position during the heel stick procedure. Experimental 2: Facilitated Tucking Position with the Nesting Bed (Tortoise Neo Bed), the facilitated tucking position will be given by the clinic nurse with the nesting bed during the heel stick collection procedure.

Facilitated tucking position

Eligibility Criteria

• Age: 24 Weeks - 37 Weeks
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Adjusted gestational age of 28-36(+6) weeks at time of registration

You may not qualify if:

• Mechanical ventilation,
• Major congenital abnormalities,
• Surgical or severe medical morbidity (bronchopulmonary dysplasia, NEC, sepsis, or intraventricular bleeding)
• The mother is under 18 years of age
• The mother is not willing to do kangaroo care

Sponsors & Collaborators

• Selcuk University: lead
• The Scientific and Technological Research Council of Turkey: collaborator

Study Sites (1)

Selcuk University

Konya, Selcuklu, 42060, Turkey (Türkiye)

Location

Related Publications (1)

• Tas Arslan F, Akkoyun S, Kucukoglu S, Kocoglu-Tanyer D, Konak M, Soylu H. Effect of kangaroo mother care on cerebral oxygenation, physiological parameters, and comfort levels in late-premature infants: A randomized controlled trial. Midwifery. 2024 Oct;137:104096. doi: 10.1016/j.midw.2024.104096. Epub 2024 Jul 7.

  PMID: 39024964 DERIVED

MeSH Terms

Conditions

Premature Birth

Interventions

Kangaroo-Mother Care Method

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Patient Positioning; Patient Care; Therapeutics; Infant Care; Child Care; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Fatma Tas Arslan, Prof

  Selcuk University

  STUDY DIRECTOR

• Sibel Kucukoglu, assoc. prof.

  Selcuk University

  STUDY DIRECTOR

• Deniz Kocoglu-Tanyer, assoc. prof.

  Selcuk University

  STUDY CHAIR

• Hanifi Soylu, Prof

  Selcuk University

  STUDY CHAIR

• Murat Konak, assoc. prof.

  Selcuk University

  STUDY DIRECTOR

• Sevinc Akkoyun, Msc

  Konya Ereğli State Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Single (Participant, Outcomes Assessor)
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: First sub purpose was designed as a single blind, parallel group, randomized controlled pre-test post-test order. Second sub purpose was designed as a single blind, parallel group, two intervention groups in pre-test and post-test order, and a randomized controlled control group.

Study Record Dates

• First Submitted: January 15, 2021
• First Posted: January 26, 2021
• Study Start: December 20, 2020
• Primary Completion: October 20, 2021
• Study Completion: December 31, 2021
• Last Updated: April 18, 2023

Record last verified: 2023-04

Locations

TU (1)