NCT01851668

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jun 2013

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 8, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 10, 2013

Completed
22 days until next milestone

Study Start

First participant enrolled

June 1, 2013

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2017

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2017

Completed
Last Updated

September 12, 2017

Status Verified

January 1, 2017

Enrollment Period

4.3 years

First QC Date

May 8, 2013

Last Update Submit

September 11, 2017

Conditions

Preterm Birth

Keywords

vibrationnoisetransferintraventricular hemorrhage

Outcome Measures

Primary Outcomes (1)

  • Quantification of whole body vibration

    Use of multi-axis accelerometers to quantify vibration and shocks experienced by the head, body and incubator. Calculation of A(8) according to ISO.

    during transfer

Secondary Outcomes (5)

  • Noise exposure

    During transfer

  • Cranial ultrasound imaging to quantify/identify intraventricular haemorrhage

    First 28 days of life

  • Evidence of excess stress or neuronal injury

    first week following transfer

  • Quantification of stresses during first week of life

    7 days of life

  • NIRS measurement of cerebral saturations

    During ambulance transfer

Study Arms (3)

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

Eligibility Criteria

Age30 Minutes - 3 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Hospital born preterm infants

You may qualify if:

  • \<31 weeks gestation
  • \<= 3 days old

You may not qualify if:

  • major congenital abnormality
  • survival unlikely

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nottingham University Hospitals NHS Trust

Nottingham, NG72UH, United Kingdom

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood and urine

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Officials

  • Don Sharkey, PhD

    University of Nottingham

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 8, 2013

First Posted

May 10, 2013

Study Start

June 1, 2013

Primary Completion

August 31, 2017

Study Completion

September 1, 2017

Last Updated

September 12, 2017

Record last verified: 2017-01

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)