| CTRI Number |
CTRI/2024/05/067066 [Registered on: 09/05/2024] Trial Registered Prospectively |
| Last Modified On: |
08/05/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Other |
|
Public Title of Study
|
Utility of automated control of oxygen delivery in preterm infants |
|
Scientific Title of Study
|
Influence of closed loop automated control of oxygen (CLACO) on time spent by the infant within the target saturation range, and oxygen requirement in South Indian preterm infants under 34 weeks. |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| SKSH/IEC/2024/4/62 dated 04.03.2024 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Santhanakrishnan Ramakrishnan |
| Designation |
Consultant Neonatal paediatrician |
| Affiliation |
SKS Hospital and Postgraduate Medical Institute |
| Address |
Clinic number 89
SKS Hospital and Postgraduate Medical Institute
23 SKS Hospital Road Alagapuram Salem
23 SKS Hospital Road Alagapuram Salem 636004
Salem
TAMIL NADU
636004
India |
| Phone |
9655319192 |
| Fax |
|
| Email |
ramakrishnan.s@sksh.ac.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Santhanakrishnan Ramakrishnan |
| Designation |
Consultant Neonatal paediatrician |
| Affiliation |
SKS Hospital and Postgraduate Medical Institute |
| Address |
Clinic number 89
SKS Hospital and Postgraduate Medical Institute
23 SKS Hospital Road Alagapuram Salem
23 SKS Hospital Road Alagapuram Salem 636004
Salem
TAMIL NADU
636004
India |
| Phone |
9655319192 |
| Fax |
|
| Email |
ramakrishnan.s@sksh.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Santhanakrishnan Ramakrishnan |
| Designation |
Consultant Neonatal paediatrician |
| Affiliation |
SKS Hospital and Postgraduate Medical Institute |
| Address |
Clinic number 89
SKS Hospital and Postgraduate Medical Institute
23 SKS Hospital Road Alagapuram Salem
23 SKS Hospital Road Alagapuram Salem 636004
Salem
TAMIL NADU
636004
India |
| Phone |
9655319192 |
| Fax |
|
| Email |
ramakrishnan.s@sksh.ac.in |
|
|
Source of Monetary or Material Support
|
| SKS Hospital and Postgraduate Institute
23 SKS Hospital Road
Alagapuram
Salem 636004 |
|
|
Primary Sponsor
|
| Name |
Nil |
| Address |
Not applicable |
| Type of Sponsor |
Other [Not applicable] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Santhanakrishnan Ramakrishnan |
SKS Hospital and Postgraduate Medical Institute |
First floor NICU, Department of Neonatology and Paediatrics
23 SKS Hospital Road,
Alagapuram
Salem 636004
Salem
TAMIL NADU |
9655319192
ramakrishnan.s@sksh.ac.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J840||Alveolar and parieto-alveolar conditions, (2) ICD-10 Condition: J840||Alveolar and parieto-alveolar conditions, (3) ICD-10 Condition: J840||Alveolar and parieto-alveolar conditions, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Closed loop automated control of oxygen (Oxygenie, SLE 6000) |
Each baby requiring respiratory support, will spend 8 hours monitored by closed loop automated control of oxygen (Oxygenie, SLE 6000 device) (CLACO arm). |
| Comparator Agent |
Manual Control Of Oxygen |
The same babies from the intervention group requiring respiratory support will be crossed over and monitored manually by nurses, using the traditional manual control of oxygen for a period of 8 hours. (MCO arm). |
|
|
Inclusion Criteria
|
| Age From |
0.00 Day(s) |
| Age To |
28.00 Day(s) |
| Gender |
Both |
| Details |
Infants born under 34 weeks gestation who require respiratory support, either invasive or non-invasive ventilation, for a medical indication. |
|
| ExclusionCriteria |
| Details |
Babies with any congenital malformation including congenital heart disease, diaphragmatic hernia, cystic pulmonary airway malformation or any other cardio respiratory malformation were excluded. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Proportion of time spent by the infants within the target oxygen saturation range will be compared between CLACO arm and MCO arm. |
16 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Concentration of FiO2 required to maintain target oxygen saturation compared between CLACO arm and MCO arm. |
16 hours |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
28/05/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
As per International and National clinical guidelines, all preterm babies born under 34 weeks gestation are required to achieve a saturation target of 91- 95% to prevent hyperoxia/hypoxia related complications. Currently, nurses manually adjust oxygen supply to maintain target saturations. However, evidence shows that such manual control of oxygen (MCO) therapy is less successful in achieving precise targeted saturation in these vulnerable infants. Closed loop automated control of oxygen (CLACO) has been proven to achieve significant improvement in time spent by the infant within that targeted saturation range.
This is a prospective crossover study where each baby requiring respiratory support, will spend 8 hours monitored by closed loop automated control of oxygen (Oxygenie, SLE 6000 device) (CLACO arm).
The same babies from the intervention group requiring respiratory support will be crossed over and monitored manually by nurses, using the traditional manual control of oxygen for a period of 8 hours. (MCO arm).
Aims: Does automated control of oxygen using a CLACO device in South Indian preterm babies result in increased proportion of time spent within the targeted saturation range compared to manual control of oxygen (MCO)? Objectives: 1) We would like to compare the percentage of time spent by the infant in three different saturation ranges including the target saturation range between 91 to 95%. This comparison would be between the CLACO group and the MCO group. 2) To find out if there is any significant difference in the percentage of oxygen required to maintain target saturation range between the two groups (CLACO vs MCO). |