320 Participants Needed

PICC Placement for Peripheral Catheterization in Newborns

AS
Overseen ByAmuchou Soraisham, MD
Age: < 18
Sex: Any
Trial Phase: Academic
Sponsor: University of Calgary
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 6 JurisdictionsThis treatment is already approved in other countries

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether participants must stop taking their current medications.

What data supports the effectiveness of the treatment Peripherally Inserted Central Venous Catheter (PICC) in newborns?

Research shows that using PICC lines in newborns can reduce mortality and health complications, especially in premature babies, by providing a reliable way to deliver medications and nutrition.12345

Is PICC placement safe for newborns?

PICC placement in newborns is generally considered safe, but there are some risks of complications. Studies show that complications can include mechanical issues like accidental removal or obstruction, and infections, with an overall complication rate of around 18.7% in pediatric cases. Proper management by the healthcare team can help reduce these risks.36789

How does the PICC treatment for newborns differ from other treatments?

The PICC (Peripherally Inserted Central Venous Catheter) treatment is unique because it involves inserting a thin, flexible tube into a vein in the arm or leg and threading it to a large vein near the heart, allowing for long-term intravenous access. This method is less invasive than traditional central venous catheters, which require insertion into larger veins in the neck or chest, making it particularly suitable for delicate newborns.1011121314

What is the purpose of this trial?

This study examines whether there is an association between the PICC insertion site and the complications necessitating PICC removal in neonates admitted to neonatal intensive care unit.

Research Team

AS

Amuchou Soraisham, MD

Principal Investigator

University of Calgary

Eligibility Criteria

This trial is for newborns of any gestational age in the NICU at Foothills Medical Centre and Alberta Children's Hospital who need a PICC line as part of their care. They must have available veins for insertion both above and below the umbilicus.

Inclusion Criteria

My baby is in the NICU and will have a PICC line inserted.
My newborn is admitted to the NICU at Foothills Medical Centre or Alberta Children's Hospital.
I have veins in both my upper and lower body that can be used for medical procedures.

Exclusion Criteria

I have an infection where they might insert a medical device.
I have a benign tumor or malformation where the medical device will be inserted.
My condition involves significant genetic abnormalities.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

PICC lines are inserted in either the upper or lower extremity of neonates and monitored for complications

4 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

  • Peripherally Inserted Central Venous Cather (PICC)
Trial Overview The study is looking into whether where the PICC line is put in (either upper or lower body) affects how often complications happen that make doctors have to take out the PICC line.
Participant Groups
2Treatment groups
Experimental Treatment
Group I: Upper Extremity InsertionExperimental Treatment1 Intervention
Peripherally Inserted Central Venous Cather (PICC) inserted in upper extremity
Group II: Lower Extremity InsertionExperimental Treatment1 Intervention
Peripherally Inserted Central Venous Cather (PICC) inserted in lower extremity

Peripherally Inserted Central Venous Cather (PICC) is already approved in European Union, United States, Canada, Japan, China, Switzerland for the following indications:

🇪🇺
Approved in European Union as PICC for:
  • Long-term IV medication administration
  • Total parenteral nutrition
  • Blood product infusions
  • Frequent blood draws
🇺🇸
Approved in United States as PICC for:
  • IV infusion of irritant medications
  • Long-term administration of medications
  • Monitoring of interventions
  • Patients with poor peripheral access
🇨🇦
Approved in Canada as PICC for:
  • Long-term IV therapy
  • Total parenteral nutrition
  • Blood product infusions
  • Frequent blood draws
🇯🇵
Approved in Japan as PICC for:
  • Long-term IV medication administration
  • Total parenteral nutrition
  • Blood product infusions
  • Frequent blood draws
🇨🇳
Approved in China as PICC for:
  • Long-term IV therapy
  • Total parenteral nutrition
  • Blood product infusions
  • Frequent blood draws
🇨🇭
Approved in Switzerland as PICC for:
  • Long-term IV medication administration
  • Total parenteral nutrition
  • Blood product infusions
  • Frequent blood draws

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Calgary

Lead Sponsor

Trials
827
Recruited
902,000+

Findings from Research

The Amplatz gooseneck snare technique successfully placed 95% of peripherally inserted central catheters (PICCs) in neonatal and pediatric patients with difficult venous access, demonstrating high efficacy in challenging cases.
This method resulted in minimal complications, with no reported cases of serious issues like osteomyelitis or deep venous thrombosis, making it a safe alternative to traditional PICC placement methods.
Snare technique for the placement of a peripherally inserted central catheter in the neonatal and pediatric patient.Monsky, WL., Garza, AS., Loh, S., et al.[2019]
In a study of 381 neonates, those with Peripherally Inserted Central Catheters (PICC) experienced significantly lower rates of septicemia and hemorrhage at the injection site compared to those with traditional IV lines, indicating that PICC is a safer option for long-term medication delivery.
The research suggests that with improved training for healthcare providers on PICC insertion and management, the minor side effects associated with this method can be further minimized, making it a viable choice for neonates in intensive care.
Assessment of the Complications of Peripherally Inserted Central Catheter in Neonates Admitted to the Intensive Care Unit: A Center's Experience in Iran.Moradi, R., Shariat, M., Farrokhzad, N., et al.[2023]
A meta-analysis of 12 randomized controlled trials found that placing a peripherally inserted central catheter (PICC) through lower limb veins in neonates significantly increases the one-time puncture success rate and allows for longer indwelling time compared to upper limb veins.
Using lower limb veins for PICC placement also reduces operation time, estimated bleeding volume, and the incidence of complications such as catheter ectopia, infections, exosmosis, and phlebitis, making it a safer option for neonatal care.
Placement of peripherally inserted central catheter through upper versus lower limb vein in neonates: A meta-analysis of randomized controlled trials.Zhao, X., Liu, Y., Li, X., et al.[2023]

References

Snare technique for the placement of a peripherally inserted central catheter in the neonatal and pediatric patient. [2019]
Assessment of the Complications of Peripherally Inserted Central Catheter in Neonates Admitted to the Intensive Care Unit: A Center's Experience in Iran. [2023]
Placement of peripherally inserted central catheter through upper versus lower limb vein in neonates: A meta-analysis of randomized controlled trials. [2023]
Peripherally inserted central venous catheters: frequency of complications in premature newborn depends on the insertion site. [2021]
Reducing peripherally inserted central catheters in the neonatal intensive care unit. [2018]
Peripherally inserted central venous catheters in critically ill premature neonates. [2017]
[Evaluation of peripherally inserted central catheters in a pediatric population]. [2018]
Complication profiles of central and non-central 1 Fr PICCs in neonates weighing [2014]
Peripherally inserted central venous catheter-associated complications exert negative effects on body weight gain in neonatal intensive care units. [2018]
Determination of the antimalarial drug piperaquine in small volume pediatric plasma samples by LC-MS/MS. [2018]
Pharmacokinetics of primaquine in patients with P. vivax malaria. [2019]
Unfractionated bone marrow cells attenuate paraquat-induced glomerular injury and acute renal failure by modulating the inflammatory response. [2018]
Nephrotoxicity of pyrroloquinoline quinone in rats. [2013]
[Combined chemotherapy of ovarian cancer with special reference to carboquone]. [2013]
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