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Preterm Infant Transport Stress (PremiTranS) Study (PremiTranS)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01851668
First Posted: May 10, 2013
Last Update Posted: September 12, 2017
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.
Information provided by (Responsible Party):
University of Nottingham
  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 ]
    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 ]
    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
Blood and urine

Enrollment: 30
Study Start Date: June 2013
Study Completion Date: September 1, 2017
Primary Completion Date: August 31, 2017 (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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   up to 3 Months   (Child)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

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


Locations
United Kingdom
Nottingham University Hospitals NHS Trust
Nottingham, United Kingdom, NG72UH
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
First Submitted: May 8, 2013
First Posted: May 10, 2013
Last Update Posted: September 12, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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