The Effect of Schumann Resonance on Preterm Newborns

December 2, 2021 updated by: Hsiao-Ling Chuang, Chung Shan Medical University

Application of Schumann Resonance on Premature Infant

Body weight gain is crucial for preterm newborns, especially those with a low birth weight. Owing to their noninvasive, noncontact, and non-pharmaceutical properties, extremely low frequency electromagnetic fields (ELF-EMFs) are a promising medium of alternative and complementary therapy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Sixty-one preterm newborns of 32-35 weeks' gestational age were recruited from the neonatal intensive care unit of the Chung Shan Medical University Hospital and randomly assigned to one of two groups: the experimental group (n = 31) or the control group (n = 30). Both groups received the same medical care, but the experimental group was exposed to ELF-EMFs until discharge.

Study Type

Interventional

Enrollment (Actual)

61

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Taichung, Taiwan
        • Chung Shan Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 months to 9 months (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • gestational age (GA) between 32 and 35 weeks
  • Neonatal Therapeutic Intervention Scoring System (NTISS) score <9

Exclusion Criteria:

  • (1) a diagnosis of congenital anomaly, intrauterine growth retardation, cerebral palsy, or hydrocephalus; (2) an NTISS score>9

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Extremely low frequency electromagnetic fields
After parental permission for participation was obtained, the preterm newborns were enrolled and divided into the experimental group, which received ELF-EMF therapy after a pretest in addition to regular medical care, and the control group, which received regular medical care only, using a random number table.
Device: extremely low frequency electromagnetic fields
extremely low frequency electromagnetic fields
Other: control group
routine care
Other: routine care
routine care

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Baseline body weight gain at 4 weeks
Time Frame: Baseline, week1, week2, week3, week4.
Although the preterm newborns' body weight was recorded daily, the differences in body weight gain between the two groups were compared every week.The body weights of the preterm newborns were recorded using the same weighing scale at the same time every day.
Baseline, week1, week2, week3, week4.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Baseline sleep quality at 4 weeks
Time Frame: Baseline, week1, week2, week3, week4.
The preterm newborns' sleep quality was recorded daily, the differences in sleep quality between the two groups were compared every week. The preterm' sleep quality was recorded by the sleep tracking devices of Fitbit Alta HR. The correlation coefficient between Alta HR and PSG was 0.85~0.87.
Baseline, week1, week2, week3, week4.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chung Shan Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 8, 2019

Primary Completion (Actual)

February 1, 2021

Study Completion (Actual)

June 5, 2021

Study Registration Dates

First Submitted

November 9, 2021

First Submitted That Met QC Criteria

December 2, 2021

First Posted (Actual)

December 7, 2021

Study Record Updates

Last Update Posted (Actual)

December 7, 2021

Last Update Submitted That Met QC Criteria

December 2, 2021

Last Verified

December 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CS19049

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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