Preterm Infant Transport Stress (PremiTranS) Study (PremiTranS)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01851668|
Recruitment Status : Completed
First Posted : May 10, 2013
Last Update Posted : September 12, 2017
|Condition or disease|
Show Detailed Description
|Study Type :||Observational|
|Actual Enrollment :||30 participants|
|Official Title:||Preterm Infant Transport Stress (PremiTranS) Study - A Feasibility Study of the Impact of Inter-hospital Transport on the Preterm Infant|
|Study Start Date :||June 2013|
|Primary Completion Date :||August 31, 2017|
|Study Completion Date :||September 1, 2017|
Preterm inter-hospital transfers
preterm infants <31 weeks gestation and <=day 3 of life
Preterm infants inborn
Preterm infants <31 weeks gestation and <=3 days old born and remaining at same hospital.
Ex-preterm infants back transfered
Mature ex-preterm infants transferred back to referring hospital
- Quantification of whole body vibration [ Time Frame: during transfer ]Use of multi-axis accelerometers to quantify vibration and shocks experienced by the head, body and incubator. Calculation of A(8) according to ISO.
- Noise exposure [ Time Frame: During transfer ]Measure total noise exposure (dBA) during transfer compared with NICU exposure.
- Cranial ultrasound imaging to quantify/identify intraventricular haemorrhage [ Time Frame: First 28 days of life ]IVH assessment by cranial USS
- Evidence of excess stress or neuronal injury [ Time Frame: first week following transfer ]Plasma Copeptin and urinary S100b measurements
- Quantification of stresses during first week of life [ Time Frame: 7 days of life ]Validated stressor score
- NIRS measurement of cerebral saturations [ Time Frame: During ambulance transfer ]Use of NIRS during interhopsital transfer to assess cerebral saturations when compared to control area (thigh)
Biospecimen Retention: Samples Without DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01851668
|Nottingham University Hospitals NHS Trust|
|Nottingham, United Kingdom, NG72UH|
|Principal Investigator:||Don Sharkey, PhD||University of Nottingham|