Evaluation of Cerebral Oxygenation Results in Premature Infant
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
The general purpose of this project is; To determine the effect of kangaroo care and facilitated tucking position on cerebral oxygenation (rSO2) in premature infants.
In this context, the study has two sub-objectives. First sub purpose; to determine the effect of kangaroo care application given to premature inafants hospitalized in the NICU with the mother on cerebral oxygenation (rSO2), physiological parameters (heart rate, peripheral oxygen saturation (SpO2) and respiratory rate) and comfort / comfort levels.
This study was designed as a single blind, parallel group, pre-test and post-test randomized controlled trial.
First sub purpose; total sample size was determined as 40 preterm babies (20 in each group). Block randomization was used in this study. During the data collection phase, the purpose of the study will be explained to the parents of preterm infants by the researcher, and written consent will be obtained from the parents who agree to participate in the study through the "Informed Consent Form". Introductory Information Form, Physiological Parameter and rSO2 Follow-up Chart and Neonatal Comfort Scale created by the researcher will be used.
Second sub purpose; to determine the effect of facilitated tucking position on the infant's cerebral oxygenation (rSO2), physiological parameters (heart peak beat, SpO2 and respiratory rate), pain and comfort / comfort levels during the heel stick procedure.
This study was designed as a single blind, parallel group, two intervention groups in pre-test and post-test order, and a randomized controlled control group.
Second sub purpose; the total sample size was determined as 66 (22 in each group). Block randomization was used in this study. During the data collection phase, the purpose of the study will be explained to the parents of preterm infants by the researcher, and written consent will be obtained from the parents who agree to participate in the study through the "Informed Consent Form". The Introductory Information Form, Physiological Parameters and rSO2 Tracking Chart, PIPP-R and Neonatal Comfort Scale created by the researcher will be used.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Kangaroo care 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
Experimental: Kangaroo care The mother kangaroo will care for at least 60 minutes.
|
| Experimental: Facilitated tucking position 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
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.
|
Outcome Measures
Primary Outcome Measures
- rSO2 level [24 weeks]
Defines the change of rSO2 level before, during and after kangaroo care and heel prick.
- Physiological parameters [24 weeks]
body temperature in infants.
- Physiological parameters [24 weeks]
heart rate in premature infants.
- Physiological parameters [24 weeks]
peripheral oxygen saturation (SpO2) in premature infants.
- Physiological parameters [24 weeks]
respiratory rate in premature infants.
Secondary Outcome Measures
- Premature Infant Pain Profile Scale-Revised (PIPP-R) [24 weeks]
The PIPP-R scale includes 3 behavioral (frowning, squeezing eyes, nasolobial-groove), 2 physiological (heart rate and oxygen saturation) and 2 contextual (behavioral state and gestational age) items used in the assessment of pain in newborns. The items of the scale are scored as 3, 2, 1, 0 ((0-6 points that the pain is mild, 7-12 points is moderate, and 13-21 points is at a severe level.)
- Neonates The COMFORTneo Scale [24 weeks]
The scale consists of 7 items: muscle tone, alertness, facial tension, calmness / agitation, body movements, respiratory response, and crying. The lowest possible score from Newborn Comfort Behavior Scale is 6 and the highest score is 30. High scores indicate that the baby is not comfortable.
Eligibility Criteria
Criteria
Inclusion Criteria:
- Adjusted gestational age of 28-36(+6) weeks at time of registration
Exclusion Criteria:
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Mechanical ventilation,
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Major congenital abnormalities,
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Surgical or severe medical morbidity (bronchopulmonary dysplasia, NEC, sepsis, or intraventricular bleeding)
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The mother is under 18 years of age
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The mother is not willing to do kangaroo care
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Selcuk University | Konya | Selcuklu | Turkey | 42060 |
Sponsors and Collaborators
- Selcuk University
- The Scientific and Technological Research Council of Turkey
Investigators
- Study Director: Fatma Tas Arslan, Prof, Selcuk University
- Study Director: Sibel Kucukoglu, assoc. prof., Selcuk University
- Study Chair: Deniz Kocoglu-Tanyer, assoc. prof., Selcuk University
- Study Chair: Hanifi Soylu, Prof, Selcuk University
- Study Director: Murat Konak, assoc. prof., Selcuk University
- Study Director: Sevinc Akkoyun, Msc, Konya Ereğli State Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2021/42