Preterm Infant Transport Stress (PremiTranS) Study

This study is currently recruiting participants.
Verified February 2014 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 10, 2014
Last verified: February 2014
  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 2014
Estimated Primary Completion Date: May 2014 (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
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
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

No publications provided

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 10, 2014
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 April 22, 2014