PICC Placement for Peripheral Catheterization in Newborns

Overseen By Amuchou Soraisham, MD

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: University of Calgary

Disqualifiers: Local infection, Hemangioma, Major chromosomal anomalies

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 6 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 4 weeks

320 Participants Needed

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. ^{1 2 3 4 5}

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. ^{3 6 7 8 9}

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. ^{10 11 12 13 14}

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

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

Group I: Upper Extremity Insertion Experimental Treatment 1 Intervention

Peripherally Inserted Central Venous Cather (PICC) inserted in upper extremity

Group II: Lower Extremity Insertion Experimental Treatment 1 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

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

In a study of 62 premature neonates, using the axillary vein for PICC line insertion resulted in 12 times fewer line-related complications, such as inflammation and infection, compared to other insertion sites.

Neonates with axillary PICC lines were also seven times more likely to have their lines removed due to achieving full enteral nutrition, indicating a positive outcome related to their feeding progress.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Peripherally inserted central venous catheters: frequency of complications in premature newborn depends on the insertion site. Panagiotounakou, P., Antonogeorgos, G., Gounari, E., et al.[2021]

A quality improvement initiative in a neonatal intensive care unit led to a 37.5% reduction in the number of peripherally inserted central catheters (PICCs) placed in infants with umbilical venous catheters, from 77.9% to 48.7%.

Importantly, this reduction in PICC usage did not result in an increase in central line-associated bloodstream infections, indicating that the intervention was both effective and safe.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reducing peripherally inserted central catheters in the neonatal intensive care unit. Vachharajani, AJ., Vachharajani, NA., Morris, H., et al.[2018]

In a study of 90 very low birth weight (VLBW) infants, peripherally inserted central venous catheters (PICCs) were successfully placed in 62 patients, demonstrating a high success rate of 87.3% for catheter insertion.

The use of PICCs in both VLBW and extremely low birth weight (ELBW) infants was found to be safe, with no significant increase in complication rates for ELBW infants, making them a valuable option for administering long-term antibiotics and nutrition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Peripherally inserted central venous catheters in critically ill premature neonates. Ozkiraz, S., Gokmen, Z., Anuk Ince, D., et al.[2017]

In a study of 57 pediatric patients, peripherally inserted central catheters (PICCs) demonstrated a high technical success rate of 95.5% with minimal sedation required, indicating that PICCs are a safe and effective option for central venous access in children.

The overall complication rate was 18.7%, primarily due to mechanical issues, suggesting that while PICCs are feasible for pediatric use, careful management and monitoring are essential to minimize risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Evaluation of peripherally inserted central catheters in a pediatric population]. Baudin, G., Occelli, A., Boyer, C., et al.[2018]

In a study of 123 neonates, both central and non-central 1 Fr peripherally inserted central venous catheters (PICCs) were found to have similar complication profiles, with catheter occlusion being the most common issue at 42%.

Non-central PICCs are deemed safe and effective for providing intravascular access in neonates weighing less than 1500 grams when prolonged intravenous access is necessary.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Complication profiles of central and non-central 1 Fr PICCs in neonates weighing Can, E., Salihoğlu, O., Oztürk, A., et al.[2014]

In a study of 304 premature infants in the NICU, nearly 10% experienced complications from peripherally inserted central venous catheters (PICC), with a higher risk in infants weighing 1,500 grams or less.

Both infectious and non-infectious complications from PICC placement were linked to significant decreases in body weight gain, indicating that these complications can adversely affect the health and growth of premature infants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Peripherally inserted central venous catheter-associated complications exert negative effects on body weight gain in neonatal intensive care units. Wen, J., Yu, Q., Chen, H., et al.[2018]

A sensitive LC-MS/MS method was developed for quantifying piperaquine in just 25 µl of pediatric plasma, making it suitable for studies involving small sample volumes.

The method demonstrated a linear calibration range of 1.5-250 ng/ml and a quick runtime of 3.0 minutes per sample, although the performance of the PFP columns varied by brand, which could affect results.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Determination of the antimalarial drug piperaquine in small volume pediatric plasma samples by LC-MS/MS. Kjellin, LL., Dorsey, G., Rosenthal, PJ., et al.[2018]

In a study of seven Indian patients with P. vivax malaria, primaquine (PQ) was administered at 15 mg/day for 14 days, showing a peak blood concentration of 50.7 ng/ml after 2.3 hours, with a half-life of 5.6 hours, indicating a rapid absorption and elimination profile.

The major metabolite of primaquine, PQC, had a significantly higher blood concentration compared to the parent drug, with a longer residence time in the body, but it was not detected in urine, suggesting that PQC may accumulate in the body without being excreted renally.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pharmacokinetics of primaquine in patients with P. vivax malaria. Bhatia, SC., Saraph, YS., Revankar, SN., et al.[2019]

In a mouse model of acute kidney injury (AKI) induced by paraquat, the injection of unfractionated bone marrow cells (BMCs) significantly improved renal function and reduced kidney damage, indicating their potential as a therapeutic intervention.

BMC treatment not only enhanced kidney recovery but also shifted the inflammatory response from a pro-inflammatory state to an anti-inflammatory one, suggesting a mechanism of action that involves modulating immune responses to promote healing.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Unfractionated bone marrow cells attenuate paraquat-induced glomerular injury and acute renal failure by modulating the inflammatory response. Gu, SY., Yeh, TY., Lin, SY., et al.[2018]

Daily intraperitoneal injections of pyrroloquinoline quinone (PQQ) at a dose of 11.5 mg/kg for 4 days in rats resulted in significant kidney damage, including necrosis and degeneration of the proximal tubular epithelium.

The treatment also led to hematuria (blood in urine) and increased serum creatinine levels, indicating impaired kidney function.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nephrotoxicity of pyrroloquinoline quinone in rats. Watanabe, A., Hobara, N., Ohsawa, T., et al.[2013]

Carboquone (CQ) showed promising results in treating ovarian cancer, with 2 out of 6 evaluated patients responding well and a higher survival rate observed in the treatment group compared to a historical control group over 3 years.

However, CQ was associated with significant side effects, affecting 89% of patients, and led to treatment discontinuation in 5 patients due to severe complications, particularly when administered intraperitoneally or alongside radiation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Combined chemotherapy of ovarian cancer with special reference to carboquone]. Sugimori, H., Kidera, Y., Matsuyama, T.[2013]

References

1. United States pubmed.ncbi.nlm.nih.gov

Snare technique for the placement of a peripherally inserted central catheter in the neonatal and pediatric patient. [2019]

2. India pubmed.ncbi.nlm.nih.gov

Assessment of the Complications of Peripherally Inserted Central Catheter in Neonates Admitted to the Intensive Care Unit: A Center's Experience in Iran. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Placement of peripherally inserted central catheter through upper versus lower limb vein in neonates: A meta-analysis of randomized controlled trials. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Peripherally inserted central venous catheters: frequency of complications in premature newborn depends on the insertion site. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

Reducing peripherally inserted central catheters in the neonatal intensive care unit. [2018]

6. United States pubmed.ncbi.nlm.nih.gov

Peripherally inserted central venous catheters in critically ill premature neonates. [2017]

7. France pubmed.ncbi.nlm.nih.gov

[Evaluation of peripherally inserted central catheters in a pediatric population]. [2018]

8. England pubmed.ncbi.nlm.nih.gov

Complication profiles of central and non-central 1 Fr PICCs in neonates weighing [2014]

9. China pubmed.ncbi.nlm.nih.gov

Peripherally inserted central venous catheter-associated complications exert negative effects on body weight gain in neonatal intensive care units. [2018]

10. England pubmed.ncbi.nlm.nih.gov

Determination of the antimalarial drug piperaquine in small volume pediatric plasma samples by LC-MS/MS. [2018]

11. Germany pubmed.ncbi.nlm.nih.gov

Pharmacokinetics of primaquine in patients with P. vivax malaria. [2019]

12. England pubmed.ncbi.nlm.nih.gov

Unfractionated bone marrow cells attenuate paraquat-induced glomerular injury and acute renal failure by modulating the inflammatory response. [2018]

13. Japan pubmed.ncbi.nlm.nih.gov

Nephrotoxicity of pyrroloquinoline quinone in rats. [2013]

14. Japan pubmed.ncbi.nlm.nih.gov

[Combined chemotherapy of ovarian cancer with special reference to carboquone]. [2013]