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Clinical trial to compare the effects of two different intravenous cannulas to place central lines in extremely premature babies.

Effect of introducer type on PICC success rates in extremely low birth weight neonates- A Randomized Controlled Trial. - NIL

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/10/075769
Enrollment
100
Registered
2024-10-24
Start date
Unknown
Completion date
Unknown
Last updated
2024-11-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: P070- Extremely low birth weight newborn

Interventions

Intervention1: 24G peripheral Intravenous cannula for placement of Peripherally Inserted Central Catheter (PICC): 24G peripheral Intravenous cannula (NEOCAN or BD/NEOFLON TM PRO, Global Medikit Limite

Sponsors

Surya Childrens Medicare Pvt Ltd
Lead Sponsor
DEENANATH MANGESHKAR HOSPITAL AND RESEARCH CENTRE
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: Extremely low birth weight with gestational age less than 29weeks with following indications for PICC 1) Need for parenteral nutrition for more than 5 days 2) signs of feed intolerance or Necrotising Enterocolitis 3) Gastrointestinal surgical conditions. 3) Need for multiple intravenous infusions, vasoactive fluids, hyperosmolar solutions 4) difficult Intravenous access and requiring intravenous fluids or antibiotics for more than 5 days

Exclusion criteria

Exclusion criteria: 1) presence or suspicion of severe sepsis and treated with antibiotics for less than 72hours, 2) poor skin integrity at the insertion site, 3) local bony abnormalities/fractures/skeletal dysplasia, 4) severe thrombocytopenia less than 25000 or coagulopathy International Normalised Ratio more than 2, 5) vascular anomaly of Superior Venacava or Inferior Venacava and 6) unavailability of key members of PICC core team

Design outcomes

Primary

MeasureTime frame
PICC insertion success rate defined as the proportion of infants in whom PICCs were inserted to an approximately central position, using not more than 2 attempts.Timepoint: NICU admission to discharge

Secondary

MeasureTime frame
CLABSI- central line associated blood stream infectionsTimepoint: NICU admission to discharge;Deep PICCsTimepoint: NICU admission to discharge;Local/mechanical complications- (Phlebitis, extremity oedema, thrombosis, extravasation, PICC occlusion, bleeding, stuck PICC)Timepoint: NICU admission to discharge;MortalityTimepoint: NICU admission to discharge;Non-central linesTimepoint: NICU admission to discharge;PICC migrationTimepoint: NICU admission to discharge;PICC tip malpositionTimepoint: NICU admission to discharge;Systemic complications- {Pleural effusion, Chylothorax, embolism, Irregular heart rate (arrythmias), cardiac tamponade, phrenic nerve injury}Timepoint: NICU admission to discharge

Countries

India

Contacts

Public ContactAbhishek Srinivas

Surya Childrens Medicare Pvt Ltd.

abhisrinivas1068@gmail.com02261538911

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026