Preterm Infant Transport Stress (PremiTranS) Study (PremiTranS)

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2016 by University of Nottingham
Sponsor:
Information provided by (Responsible Party):
University of Nottingham
ClinicalTrials.gov Identifier:
NCT01851668
First received: May 8, 2013
Last updated: February 25, 2016
Last verified: February 2016
  Purpose
This is an observational pilot study to quantify the amount of vibration, noise, physiological and biochemical instability that premature babies are exposed to during inter-hospital transport.

Condition
Preterm Birth

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Preterm Infant Transport Stress (PremiTranS) Study - A Feasibility Study of the Impact of Inter-hospital Transport on the Preterm Infant

Resource links provided by NLM:


Further study details as provided by University of Nottingham:

Primary Outcome Measures:
  • Quantification of whole body vibration [ Time Frame: during transfer ] [ Designated as safety issue: No ]
    Use of multi-axis accelerometers to quantify vibration and shocks experienced by the head, body and incubator. Calculation of A(8) according to ISO.


Secondary Outcome Measures:
  • Noise exposure [ Time Frame: During transfer ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    IVH assessment by cranial USS

  • Evidence of excess stress or neuronal injury [ Time Frame: first week following transfer ] [ Designated as safety issue: No ]
    Plasma Copeptin and urinary S100b measurements

  • Quantification of stresses during first week of life [ Time Frame: 7 days of life ] [ Designated as safety issue: No ]
    Validated stressor score


Biospecimen Retention:   Samples Without DNA
Blood and urine

Estimated Enrollment: 60
Study Start Date: June 2013
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: May 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   up to 3 Months   (Child)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Hospital born preterm infants
Criteria

Inclusion Criteria:

  • <31 weeks gestation
  • <= 3 days old

Exclusion Criteria:

  • major congenital abnormality
  • survival unlikely
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01851668

Contacts
Contact: Don Sharkey, PhD don.sharkey@nottingham.ac.uk

Locations
United Kingdom
Nottingham University Hospitals NHS Trust Recruiting
Nottingham, United Kingdom, NG72UH
Contact: Don Sharkey, PhD       don.sharkey@nottingham.ac.uk   
Principal Investigator: Don Sharkey, BM BS PhD         
Sponsors and Collaborators
University of Nottingham
Investigators
Principal Investigator: Don Sharkey, PhD University of Nottingham
  More Information

Responsible Party: University of Nottingham
ClinicalTrials.gov Identifier: NCT01851668     History of Changes
Other Study ID Numbers: 12063 
Study First Received: May 8, 2013
Last Updated: February 25, 2016
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by University of Nottingham:
vibration
noise
transfer
intraventricular hemorrhage

Additional relevant MeSH terms:
Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications

ClinicalTrials.gov processed this record on July 28, 2016