| CTRI Number |
CTRI/2018/11/016329 [Registered on: 14/11/2018] Trial Registered Prospectively |
| Last Modified On: |
23/11/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device
Preventive
Process of Care Changes |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparison of central lines in preventing infections in preterm infants |
|
Scientific Title of Study
|
Comparison of UVC with PICC line insertion as a primary central line for reducing late onset sepsis in preterm infants with birth weight less than 1250grams: A randomised control trail |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
B Subash Arun |
| Designation |
DNB Neonatology, 1st year |
| Affiliation |
Fernandez Hospital |
| Address |
Department of Neonatology, Second floor, 4-1-1230, Fernandez Hospital, Bogulkunta, Hyderabad-
Hyderabad
TELANGANA
500001
India |
| Phone |
|
| Fax |
|
| Email |
drsubhash_b@fernandezhospital.com |
|
Details of Contact Person
Scientific Query
|
| Name |
SRINIVAS MURKI |
| Designation |
Chief Neonatologist |
| Affiliation |
Fernandez Hospital |
| Address |
Department of Neonatology, Unit 2, Second floor, 4-1-1230, Fernandez Hospital, Bogulkunta, Hyderabad-
Hyderabad
TELANGANA
500001
India |
| Phone |
|
| Fax |
|
| Email |
srinivasmurki2001@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
SRINIVAS MURKI |
| Designation |
Chief Neonatologist |
| Affiliation |
Fernandez Hospital |
| Address |
Department of Neonatology, Second floor, 4-1-1230, Fernandez Hospital, Bogulkunta, Hyderabad-
Hyderabad
TELANGANA
500001
India |
| Phone |
|
| Fax |
|
| Email |
srinivasmurki2001@gmail.com |
|
|
Source of Monetary or Material Support
|
| Fernandez Hospital Educational And Research Foundation, Fernandez Hospital, Bogulkunta, Hyderabad, PIN 5000001 |
|
|
Primary Sponsor
|
| Name |
FH Educational and Research Foundation |
| Address |
Bogulkunta, Hyderabad |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| B Subash ARun |
FERNANDEZ HOSPITAL |
4-1-1230, FERNANDEZ HOSPITAL, BOGULKUNTA, HYDERABAD
Hyderabad
TELANGANA |
9392470351
drsubhash_b@fernandezhospital.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Fernandez Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: P369||Bacterial sepsis of newborn, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Peripherally Inserted Central Line |
A PICC line would be inserted in the upper limb or lower limb ensuring the tip is at the junction of SVC and Right atrium or in the IVC |
| Comparator Agent |
Umbilical Venous Central Line |
UVC would be inserted ensuring the tip is just above the diaphragm |
|
|
Inclusion Criteria
|
| Age From |
0.00 Day(s) |
| Age To |
30.00 Day(s) |
| Gender |
Both |
| Details |
All preterm infants with birth weight <1250grams and eligible for a central line placement |
|
| ExclusionCriteria |
| Details |
Those with major malformations, maternal chorioamnionits |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Late Onset Sepsis |
48 hours from insertion to 48 hours after removal of Central line |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Malposition of lIne,Thrombophlebilits, Local Infections, bleeding at site insertion, failure rates, survival, DIC, probable sepsis, Thrombus formation |
till discharge of the neonate from the unit |
|
|
Target Sample Size
|
Total Sample Size="338"
Sample Size from India="338"
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
14/11/2018 |
| 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="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
In this RCT we are comparing UVC with PICC to reduce the incidence of late onset sepsis in preterm infants with birth weight <1250grams. Only infants requiring central line and admitted to the neonatal unit would be recruited in this trail. UVC would be inserted with the tip just above the diaphragm and PICC would be inserted either in the upper limp or in the lower limb with the tip either at SVC to right atrium junction or in the IVC respectively. Late Onset sepsis (blood culture positive) with onset 48 hours after line insertion till 48 hours after line removal would be primary outcome of this study. Probable sepsis, line insertion related complication and survival till discharge would be the secondary outcomes. Inability to insert the line on two attempts or removal of line due to malposition or immediate complication would be considered as a failure. UVC would be removed at day 10 or earlier if not clinically indicated whereas PICC would be removed at any time clinical indication is not required. 154 infants would be enrolled in PICC group and 184 infants in UVC group assuming 25% LOS in UVC group and 15% in the PICC group with an alpha error of 5% and Power of 80% and assumed failure rate of 20% in UVC group. This would a RCT with computer generated random numbers and stratified for birth weight <1000 grams and 1000 to 1249 grams. |