Maturational Changes in Newborn Infants

NCT02501512 | Completed

• 1 other identifier: 2015136
• Study Type: observational
• Target: 13
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to extract and discriminate the signals of respiration, heart rate and swallowing from a standard ECG and EMG signal obtained using a special neonatal gastric tube. These signals will be compared with the standard monitoring signals in the neonatal intensive care unit (NICU). Further, they will be used to search for objectively quantifiable maturational coordination processes of respiration, heart rate and swallowing. Lastly, this study aims to identify changes in ECG/EMG-signals as a result of external stimuli (e.g. nursing interventions) in the NICU.

Conditions

Immature Newborn; Abnormal Coordination

Keywords

transesophageal signal; swallowing; newborn

Outcome Measures

Primary Outcomes (3)

• Respiratory rate determined by transoesophageal EMG

  5 consecutive days during first two weeks of life

• Heart rate determined by transoesophageal ECG

  5 consecutive days during first two weeks of life

• Swallowing act determined by transoesophageal EMG

  5 consecutive days during first two weeks of life

Secondary Outcomes (3)

• Agreement of beat-to-beat heart rate (inter-beat-interval) obtained from EMG signals with corresponding values from NICU monitoring

  5 consecutive days during first two weeks of life

• Change of average value of respiratory rate over the measurement period

  5 consecutive days during first two weeks of life

• Change of average value of heart rate over the measurement period

  5 consecutive days during first two weeks of life

Eligibility Criteria

• Age: 4 Days - 10 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

15 infants hospitalized in the NICU of the University Children's Hospital Basel who were born between 32 and 42 weeks gestational age in the course of their first two weeks of life.

You may qualify if:

• Informed Consent by legal representatives as documented by signature
• Gestational age of 32 to 42 weeks
• Study start possible in the course of participant's 4th-10th day of life
• Presumed NICU stay ≥ 5 days from study start onwards
• Need for a gastric feeding tube for clinical reasons for ≥ 5 days from study start onwards

You may not qualify if:

• Major congenital malformations
• Circulatory instability (in need of therapy with vasoactive substances)
• Endotracheal ventilation
• Infant in extremis

Sponsors & Collaborators

• Sven Schulzke: lead
• Bern University of Applied Sciences: collaborator

Study Sites (1)

University Children's Hospital Basel

Basel, Canton of Basel-City, 4056, Switzerland

Location

MeSH Terms

Conditions

Ataxia

Condition Hierarchy (Ancestors)

Dyskinesias; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Sven Schulzke, Prof

  University Children's Hospital Basel

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director, Department of Neonatology

Study Record Dates

• First Submitted: July 9, 2015
• First Posted: July 17, 2015
• Study Start: July 1, 2015
• Primary Completion: March 1, 2016
• Study Completion: April 1, 2016
• Last Updated: May 13, 2016

Record last verified: 2016-05

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)