Minimising the Adverse Physiological Effects of Transportation on the Premature Infant

NCT03754439 | Unknown

• 1 other identifier: 18015
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Centralisation of neonatal intensive care has led to an increase in postnatal inter-hospital transfers within the first 72 hours of life. Studies have shown transported preterm infants have an increased risk of intraventricular haemorrhage compared to inborns. The cause is likely multi-factorial, however, during the transportation process infants are exposed to noxious stimuli (excessive noise, vibration and temperature fluctuations), which may result in microscopic brain injury. However, there is a paucity of evidence to evaluate the effect of noise and vibration exposure during transportation. In this study the investigators aim to quantify the level of vibration and noise as experienced by a preterm infant during inter-hospital transportation in ground ambulance in the United Kingdom Secondary aims of the study are to: i) measure the physiological and biochemical changes that occur as a result of ambulance transportation (ii) quantify microscopic brain injury through measurement of urinary S100B and other biomarkers (iii) evaluate the development of intraventricular haemorrhage on cranial ultrasound iv) monitor vibration and sound exposure, using a prototype measuring system, during neonatal transport using both a manikin and a small cohort of neonatal patients. v) evaluate vibration and sound exposure levels using an updated transportation system modified to reduce effects.

Conditions

Prematurity; Transfer Injury; Brain Injuries; Intraventricular Hemorrhage; Vibration; Exposure; Noise Exposure

Outcome Measures

Primary Outcomes (2)

• Vibration

  Vibration exposure levels during ambulance journey or inborn measurement for period as experienced by the infant's head \& incubator (m/s2)

  An average of 90 minutes

• Noise

  Sound exposure levels during the ambulance journey or inpatient measurement period both inside and outside the incubator (dB)

  An average of 90 minutes

Secondary Outcomes (6)

• Intraventricular haemorrhage

  Until discharge from hospital, on average 3-4 months after admission.

• Heart rate (beats per minute)

  an average of 90 min

• Pulse oximetery (oxygen saturation %)

  An average of 90 min

• Respiratory rate (breaths per minute)

  An average of 90 min

• Near infrared spectroscopy (regional oxygen saturations)

  An average of 90 min

Study Arms (2)

Inborn

* Infants born within Nottingham University hospitals * \< 32 weeks gestational age * \< 72 hours old

Behavioral: Physiological changes to noise and vibration exposure

Transported

\- Infants born outside of Nottingham University Hospitals or transferred between units Phase 1 \< 32 weeks gestational age and \<72 hours old Phase 2 any gestation and age

Behavioral: Physiological changes to noise and vibration exposure

Interventions

Physiological changes to noise and vibration exposure BEHAVIORAL

Physiological parameters (HR, RR, Sats, NIRS) will be observed during a period of stay on the neonatal unit (Inborn group) or during ambulance transportation (Transported group) whilst simultaneous measurement of noise and vibration exposure. Urine will be collected during the first 24, 48 and 72 hours post exposure for biochemical markers of brain injury (S100B) and stress (Cortisol)

Inborn; Transported

Eligibility Criteria

• Age: Up to 4 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Neonatal patients

You may qualify if:

• Infant \< 32 weeks gestation (Phase 1) or any neonatal patient (Phase 2)
• Less than 72 hours of age
• With written maternal consent

You may not qualify if:

• Lethal and/or major congenital abnormality known at study entry
• No realistic prospect of survival
• No informed consent
• Maternal death

Sponsors & Collaborators

• University of Nottingham: lead

Study Sites (1)

University Hospitals Nottingham NHS Trust

Nottingham, Nottinghamshire, NG7 2UH, United Kingdom

RECRUITING

Related Publications (1)

• Blaxter L, Yeo M, McNally D, Crowe J, Henry C, Hill S, Mansfield N, Leslie A, Sharkey D. Neonatal head and torso vibration exposure during inter-hospital transfer. Proc Inst Mech Eng H. 2017 Feb;231(2):99-113. doi: 10.1177/0954411916680235. Epub 2017 Jan 5.

  PMID: 28056712 RESULT

Biospecimen

Retention: SAMPLES WITHOUT DNA

Urine

MeSH Terms

Conditions

Premature Birth; Brain Injuries

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Don Sharkey, MBBS, PhD

  University of Nottingham

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Don Sharkey, MBBS, PhD

CONTACT

01158230602; Don.Sharkey@nottingham.ac.uk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 12, 2018
• First Posted: November 27, 2018
• Study Start: October 31, 2018
• Primary Completion: July 31, 2020
• Study Completion: July 31, 2020
• Last Updated: November 27, 2018

Record last verified: 2018-11

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)