Comparison of umbilical venous catheter and peripherally inserted central catheter in newborn babies

Completed

Conditions: 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.

Registration Number: CTRI/2015/02/005529

Lead Sponsor: Somashekhar Nimbalkar

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).xml:namespace prefix = "o" ns = "urn:schemas-microsoft-com:office:office" /

**Introduction:**

Vascular catheters are considered â€˜â€˜life lines,â€™â€™ 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 144

Inclusion Criteria

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.

Exclusion Criteria

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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
patient outcome and days needed for discharge	15 days

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1): NICU, Shree Krishna Hospital
🇮🇳
Anand, GUJARAT, India
NICU, Shree Krishna Hospital
🇮🇳Anand, GUJARAT, India
Somashekhar Nimbalkar
Principal investigator
9825087842
somu_somu@yahoo.com