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CTRI Number  CTRI/2015/02/005529 [Registered on: 11/02/2015] Trial Registered Retrospectively
Last Modified On: 06/02/2015
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Process of Care Changes 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparison of umbilical venous catheter and peripherally inserted central catheter in newborn babies 
Scientific Title of Study   A randomized controlled trial of comparison on efficacy of umbilical venous catheter versus peripherally inserted central catheter in newborn babies admitted in NICU. 
Trial Acronym  PUC 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Ashish Dongara 
Designation  Fellow 
Affiliation  Shree Krishna Hospital 
Address  Department of Pediatrics, Pramukhswami Medical College, Karamsad-Anand-Gujarat. Pin-388325

Anand
GUJARAT
388325
India 
Phone  9925788808  
Fax  02692223466  
Email  dongaraashish@yahoo.co.in  
 
Details of Contact Person
Scientific Query
 
Name  Dr Somashekhar Nimbalkar 
Designation  Professor 
Affiliation  Shree Krishna Hospital 
Address  Dept. of pediatrics, Shree Krishna Hospital, Karamsad, Anand

Anand
GUJARAT
388325
India 
Phone  9825087842  
Fax  02692223466  
Email  somu_somu@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  Dr Dipen Patel 
Designation  Associate Professor 
Affiliation  Shree Krishna Hospital 
Address  Dept. of pediatrics, Shree Krishna Hospital, Karamsad, Anand

Anand
GUJARAT
388325
India 
Phone  9825331453  
Fax  02692223466  
Email  dipenvp@charutarhealth.org  
 
Source of Monetary or Material Support  
Dr. Somashekhar Nimbalkar, Department of Pediatrics, Pramukhswami Medical College, Karamsad-Anand-Gujarat 
 
Primary Sponsor  
Name  Somashekhar Nimbalkar 
Address  Department of Pediatrics, Shree Krishna Hospital, Karamsad, Anand. 388325 
Type of Sponsor  Other [Neonatologist] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Somashekhar Nimbalkar  NICU, Shree Krishna Hospital  Department of Pediatrics, Shree Krishna Hospital, Karamsad, Anand
Anand
GUJARAT 
9825087842
02692223466
somu_somu@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Human Research Ethics Comittee of HM Patel Center For Medical Care and Education  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Sick newborns admitted to NICU, who need to require vascular access for long duration i.e. at least 7 days will be included in the study.,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Peripherally inserted central catheter  We will insert Vygon epicutaneo-cava-catheter 24G/2Fr in the saphenous or cephalic or brachial or popliteal vein 
Intervention  Umbilical Venous Catheter  We will insert Vygon Umbilical venous catheter in the umbilical vein of the neonate. 
 
Inclusion Criteria  
Age From  0.00 Day(s)
Age To  7.00 Day(s)
Gender  Both 
Details  Sick newborns admitted to NICU requiring at least 7 days of vascular access (based on clinical judgement or laboratory tests) will be included in the study after taking informed consent from the parents/guardian 
 
ExclusionCriteria 
Details  Newborn babies with local bacterial infection at the site of umbilicus or with no peripheral veins visible at the antecubital fossa or ankle, will be excluded from the study. Newborn babies with fallen umbilical stump (usually occurs after 7 days of life) will be excluded from the study. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
patient outcome and days needed for discharge  15 days 
 
Secondary Outcome  
Outcome  TimePoints 
Cost  cost of catheter and insertion cost 
complications encountered  complications attributed to the central catheter 
Duration of completion of procedure  time needed to complete procedure 
 
Target Sample Size   Total Sample Size="144"
Sample Size from India="144" 
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" 
Phase of Trial   N/A 
Date of First Enrollment (India)   11/07/2013 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

To find out which procedure i.e. either Umbilical Venous Catheter (UVC) or Peripherally Inserted Central Catheter (PICC), is more effective in terms of technique of insertion and complications in newborns admitted to Neonatal Intensive Care Unit (NICU).

Introduction:

Vascular catheters are considered ‘‘life lines,’’ indispensable in neonatal intensive care. Insertion of an intravascular catheter is the most common invasive procedure in the neonatal ICU (NICU). With every passing decade, technological innovations in catheter materials and sizes have allowed vascular access in infants who are smaller and sicker, for purposes of blood pressure monitoring, blood sampling, and infusion of intravenous fluids and medications. On the other hand, there is growing recognition of potential risks to life and limb associated with the use of intravascular catheters [1,2].

Venous catheters used in the NICU include short peripheral catheters or cannulas placed in superficial veins and longer Central Venous Catheters (CVCs) placed in larger deep veins. These include umbilical venous catheters, percutaneously placed CVCs (also known as peripherally placed central catheters, PICCs), which are soft, flexible catheters inserted into peripheral veins and threaded into the central venous system, and surgically inserted external tunnelled central catheters such as for subclavian, femoral and internal jugular veins.

CVCs provide stable intravenous access to infants who need long-term parenteral alimentation or medications [3]. In the NICU, CVCs may be in the form of umbilical venous catheters or percutaneous CVCs, also known as PICCs. PICCs have become much more prevalent than cut-downs or open surgical techniques, because the procedure is simpler to perform, relatively rapid, less expensive, and requires only mild sedation or pain relief. The catheters, made of silicone, polyurethane, or polyethylene, are widely available in sizes as small as 1.2 Fr, facilitating insertion in micropremies weighing 500 g to 700 g. Direct catheterization of the subclavian or femoral veins is resorted to in NICUs only in exceptional circumstances [4]. Complications from CVCs include injury to other vessels or organs during insertion, catheter migration or malposition with extravasation from the malpositioned catheter causing further problems, infection, thromboembolism, catheter breakage, thrombophlebitis, pericardial effusion, cardiac arrhythmias and dysfunction.

Rationale for undertaking the project:

CVCs are frequently used in NICU as most of the critical babies admitted require fluids, parenteral nutrition, medications for long duration (at least 5 to 7 days). Commonly used CVCs in newborns are UVC and PICC. Intensive literature and internet search for studies on vascular catheters in newborns was done, but I found no study which compared UVC and PICC.

This study will add that, which procedure of CVC insertion is more effective in terms of patient outcome, duration of completing the procedure and complications for UVC versus PICC. Cost analysis will also be done.

 
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