Comparison of the Results of Transcutaneous Carbon Dioxide and Oxygen Pressure in Premature Neonates Who Underwent MIST Under HHHFNC or Nasal CPAP Methods

NCT04505176 | Unknown

• 1 other identifier: KA-19071
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Intratracheal surfactant treatment is applied in Respiratory Distress Syndrome (RDS) Continious Positive Airway Pressure(CPAP) treatment. In recent clinical studies, two similar methods have been studied with a thin catheter without endotracheal intubation in the application of surfactant. In our neonatal intensive care unit, respiratory support is given with nasal CPAP and Humidified Heated High Flow Nasal Cannula (HHHFNC) instead of classical invasive (intubated) mechanical ventilation methods. In CPAP method, heated and humidified air is given a certain pressure (6-8 cmH2O), while in HHHFNC method, heated humidified air is given at a certain flow rate (6-8 L / min). This study was planned to compare the results of infants who were given surfactant with MIST (Minimal Invazive Surfactant Treatment) method under CPAP or HHHFNC support in the treatment of respiratory distress syndrome in premature babies. During surfactant application, babies will be monitored (as in all babies in the NICU) saturation, peak heart rate, perfusion index (the ratio of nonpulsatile flow in the capillary bed) and t values will be recorded. For all these reasons, monitoring of PI (Perfusion Index), PVI (plethysmographic variability index) and continuous transcutaneous PCO2 and PO2 values are of great importance for the prevention of mortality and morbidity, as well as monitoring of oxygen saturation values with pulse oximetry in premature babies. In our hospital, it was planned to take a total of 40 patients born under 32 weeks and less than 1500 grams (20 patients being in the HHHNFC, 20 patients in the CPAP group). Patients will be consecutively distributed to two groups until they reach the specified number of patients. In this study, it was aimed to monitor continuous oxygen saturation, PI, PVI, transcutaneous PO2 and PCO2 measurements just before, during and after the surfactant application and to compare the results of babies who received nCPAP and HHHFNC support. At the end of the study, all data will be entered in an SPSS (Statistical Package for the Social Sciences) file and study statistics will be made. A database will be created using SPSS software. A p value of \<0.05 was determined as the limit of significance.

Conditions

Premature Birth; Respiratory Distress Syndrome; Surfactant Deficiency Syndrome Neonatal

Keywords

surfactant therapy; prematurity; transcutaneous measurement

Outcome Measures

Primary Outcomes (2)

• Comparison of the Results of Transcutaneous Oxygen Pressure

  In this study, it was aimed to monitor continuous transcutaneous PO2 measurements just before, during and after the surfactant application and to compare the results of babies who received nCPAP and HHHFNC support.

  12 months

• Comparison of the Results of Transcutaneous Carbon dioxide Pressure

  In this study, it was aimed to monitor continuous transcutaneous PCO2 measurements just before, during and after the surfactant application and to compare the results of babies who received nCPAP and HHHFNC support.

  12months

Secondary Outcomes (1)

• Comparison of the Results of Saturation Values

  12 months

Study Arms (2)

1

20 patients being in the HHHNFC. In this study, it was aimed to monitor continuous oxygen saturation, PI, PVI, transcutaneous PO2 and PCO2 measurements just before, during and after the surfactant application and to compare the results of babies who received nCPAP and HHHFNC support.

2

20 patients in the CPAP group. In this study, it was aimed to monitor continuous oxygen saturation, PI, PVI, transcutaneous PO2 and PCO2 measurements just before, during and after the surfactant application and to compare the results of babies who received nCPAP and HHHFNC support.

Eligibility Criteria

• Age: Up to 28 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

it was planned to take a total of 40 patients born under 32 weeks and less than 1500 grams

You may qualify if:

• Premature babies under 37 weeks of sleep at Hacettepe University Neonatal Intensive Care Unit,
• Infants who have been diagnosed with respiratory distress syndrome in the first 24 hours of life, who have received surfactant treatment under the nCPAP or HHHFNC method using the MIST method,
• Babies whose informed consent was obtained from their mothers and / or fathers

You may not qualify if:

• Term babies born 37 weeks and over
• Babies monitored for intubation due to severe respiratory failure
• Babies with hemodynamically unstable, severe hypotension
• Major congenital anomalies (severe congenital heart disease, congenital diaphragmatic hernia etc.)
• Babies with chromosomal disorders
• Babies with hereditary metabolic disease
• Babies whose informed consent form could not be obtained from their mothers and / or fathers
• Babies whose mothers have early membrane rupture or chorioamnionitis
• Diabetic mother babies
• Families who want their children to leave the work at any time of the study
• Babies whose study data cannot be collected completely

Sponsors & Collaborators

• Hacettepe University: lead

Study Sites (1)

Hacettepe University

Ankara, Turkey (Türkiye)

Location

Related Links

• HHHFNC- premature infant
• nCPAP vs HHHFNC

MeSH Terms

Conditions

Premature Birth; Respiratory Distress Syndrome; Pulmonary Atelectasis

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Lung Diseases; Respiratory Tract Diseases; Respiration Disorders

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: associate professor

Study Record Dates

• First Submitted: August 1, 2020
• First Posted: August 10, 2020
• Study Start: November 30, 2020
• Primary Completion: November 30, 2021
• Study Completion: November 30, 2021
• Last Updated: August 10, 2020

Record last verified: 2020-08

Locations

TU (1)