The Effect of Schumann Resonance on Preterm Newborns

Extremely Low Birth Weight Clinical Trial

Official title:

Application of Schumann Resonance on Premature Infant

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05146752
• Other study ID #: CS19049
• Status: Completed
• Phase: N/A
• Start date: June 8, 2019
• Est. completion date: June 5, 2021

Study information

• Verified date: December 2021
• Source: Chung Shan Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 61
• Est. completion date: June 5, 2021
• Est. primary completion date: February 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 26 Weeks to 42 Weeks

Eligibility

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

Related Conditions & MeSH terms

• Birth Weight
• Extremely Low Birth Weight

Intervention

Device:
• extremely low frequency electromagnetic fields
extremely low frequency electromagnetic fields

Other:
• routine care
routine care

Locations

Country	Name	City	State
Taiwan	Chung Shan Medical University	Taichung

Sponsors (1)

Lead Sponsor	Collaborator
Chung Shan Medical University

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline body weight gain at 4 weeks	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	Change from Baseline sleep quality at 4 weeks	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.