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The efficacy of two different doses of red blood cell transfusion in preterm babies.

To evaluate the safety and effectiveness of packed red blood cell transfusions in two different doses in very low birth weight babies in neonatal intensive care unit. - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/08/072811
Enrollment
104
Registered
2024-08-21
Start date
Unknown
Completion date
Unknown
Last updated
2024-09-16

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

Conditions

Health Condition 1: D539- Nutritional anemia, unspecified

Interventions

Intervention1: Packed red blood cell (PRBC) transfusions. : PRBC transfusion in dose of 10 ml/kg body weight Intravenous route Frequency: Single dose Duration of therapy: slowly Over 4 hours Interven

Sponsors

Datta Meghe Institute of Higher Education and Research, Sawangi Meghe, Wardha,Maharashtra
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: All babies requring PRC transfusion weighing less than 1500 gram. All preterm and IUGR babies needing PRC transfusion in NICU Babies receiving PRC for any of the reasons.

Exclusion criteria

Exclusion criteria: 1. Babies with birth weight more than 1500 gm and less than 500 gram. 2. Major congenital anomalies and Congenital heart defects 3. Patient undergone exchange transfusion. 4. Parent not giving consent and not willing to participate in study.

Design outcomes

Primary

MeasureTime frame
•The primary outcome will be post transfusion change in haemoglobin and hematocrit in infants following both PRBC transfusion treatment sequences. •The total stay in the hospital and outcome in form of death. Timepoint: • Subject enrollment at the time of admission. Administration of PBRC : 0 day PRBC tolerance : 2 days primary Outcome : 1 week Tolerance and recovery: 4 week Data collection: 4-8 months analysis: 10 th month Declaration of result: 12 month

Secondary

MeasureTime frame
number of stay of days Number f patients developed NEC Correction of AnemiaTimepoint: Enrollent of subject - Day 1 PRBC Transfusion - baseline Collection of blood sample- 24 hours Assessing the risk : 1 week Outcome in form of complication: 3 weeks Secondary outcome of mortality : at the time of discharge 4-6 weeks

Countries

India

Contacts

Public ContactDr Amar Taksande

JNMC, Datta Meghe Institute of Higher Education and Research, Sawangi Meghe, Wardha,Maharashtra

amar.taksande@gmail.com9822369233

Outcome results

None listed

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