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CompletedNCT05146752Updated Dec 7, 2021

The Effect of Schumann Resonance on Preterm Newborns

An interventional study of extremely low frequency electromagnetic fields and routine care in Extremely Low Birth Weight, sponsored by Chung Shan Medical University. Completed at 1 site in Taiwan. Open to participants aged 26 Weeks to 42 Weeks, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-12-07.

Sponsored by Chung Shan Medical University · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Registered 2 years 5 months after the study started (first participant enrolled Jun 2019, registered Nov 2021).
Phase
Not applicable
Study type
Interventional
Enrollment
61
Allocation
Randomized
Ages
26 Weeks to 42 Weeks
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Extremely Low Birth Weight

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03

In context

Birth Weight

445 studies on the registry are indexed under Birth Weight; 36 are open to participants now.

This study's enrollment of 61 is below the median of 110 across 297 interventional studies indexed under Birth Weight.

Browse Birth Weight studies →

Lead sponsor

Chung Shan Medical University is the lead sponsor of 124 studies on the registry; 26 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
26 Weeks to 42 Weeks
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • (1) a diagnosis of congenital anomaly, intrauterine growth retardation, cerebral palsy, or hydrocephalus; (2) an NTISS score>9
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
61 participants (actual)

Study arms

  • 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

  • Other
    control group

    routine care

    Other: routine care

Interventions

  • Deviceextremely low frequency electromagnetic fields

    extremely low frequency electromagnetic fields

  • Otherroutine care

    routine care

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Baseline, week1, week2, week3, week4.

Secondary outcomes

  1. 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.

    Time frame: Baseline, week1, week2, week3, week4.

07

Study locations

1 site
  • Chung Shan Medical University
    Taichung, Taiwan
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 7, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05146752
Lead sponsor
Chung Shan Medical University
Responsible party
Hsiao-Ling Chuang (Assistant Professor, Chung Shan Medical University) — Principal investigator
First posted
Dec 7, 2021
Start date
Jun 8, 2019
Primary completion
Feb 1, 2021
Completion
Jun 5, 2021
Last update
Dec 7, 2021

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2021. You cannot join it, but the record below documents what was studied.

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