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The Effect of Schumann Resonance on Preterm Newborns

NCT ID: NCT05146752

Last Updated: 2021-12-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

61 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-06-08

Study Completion Date

2021-06-05

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Extremely Low Birth Weight

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

extremely low frequency electromagnetic fields

Intervention Type DEVICE

extremely low frequency electromagnetic fields

control group

routine care

Group Type OTHER

routine care

Intervention Type OTHER

routine care

Interventions

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extremely low frequency electromagnetic fields

extremely low frequency electromagnetic fields

Intervention Type DEVICE

routine care

routine care

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

26 Weeks

Maximum Eligible Age

42 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Chung Shan Medical University

OTHER

Sponsor Role lead

Responsible Party

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Hsiao-Ling Chuang

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Chung Shan Medical University

Taichung, , Taiwan

Site Status

Countries

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Taiwan

Other Identifiers

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CS19049

Identifier Type: -

Identifier Source: org_study_id