Effect of two different volumes of blood transfusion on cardiac function, cerebral and gut hemodynamics in neonates: a randomised controlled trial
| ISRCTN | ISRCTN18526805 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN18526805 |
| Protocol serial number | N0227163238 |
| Sponsor | Record Provided by the NHSTCT Register - 2006 Update - Department of Health |
| Funder | South Tees Hospitals NHS Trust (UK), NHS R&D Support Funding |
- Submission date
- 29/09/2006
- Registration date
- 29/09/2006
- Last edited
- 20/08/2015
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Neonatal Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Samir Gupta
Scientific
Scientific
South Tees Hospital Trust
The James Cook University Hospital
Marton Road
Cleveland
TS4 3BW
United Kingdom
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | Effect of two different volumes of blood transfusion on cardiac function, cerebral and gut hemodynamics in neonates: a randomised controlled trial |
| Study objectives | What are the hemodynamic effects of different volumes of blood transfusion in newborn babies: effects on cardiac output, gut and cerebral flow? |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Neonatal Diseases |
| Intervention | After taking informed consent the Ultrasonographic and Doppler assessment of cerebral flow, gut flow and cardiac function, would be done 4 hours before, and 4 and 24-30 hours after transfusion. Block randomisation with stratification as per the gestation (less than and equal to and more than 30 weeks gestation) will be done. Once eligible baby will be randomised into one of the 2 groups: 1. Volume of transfusion 20 ml per kg given over 4 hours 2. Volume of transfusion 10 ml per kg given over 2 hours and repeated with 10 ml per kg transfused over two hours from same donor, 24 hours apart Each baby will act as control pre transfusion and case post transfusion. Each consented transfusion event will be enrolled as a subject. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure(s) |
1. Effect of blood transfusion |
| Key secondary outcome measure(s) |
1. Change in gut flow |
| Completion date | 28/02/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Neonate |
| Sex | All |
| Target sample size at registration | 70 |
| Key inclusion criteria | Babies admitted to the neonatal intensive care unit and requiring blood transfusion (packed cells) as per the unit protocol and guidelines will be eligible for the study. |
| Key exclusion criteria | 1. Babies with pneumothorax, pneumomediastinum or pneumoperitoneum during study 2. Hypotension requiring changing ionotropic support at time of transfusion 3. Terminally ill babies 4. Complex congenital heart disease 5. Major congenital anomalies |
| Date of first enrolment | 01/10/2004 |
| Date of final enrolment | 28/02/2007 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
South Tees Hospital Trust
Cleveland
TS4 3BW
United Kingdom
TS4 3BW
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
