NCT07187232

Brief Summary

In 2020, 11.6% of newborns are delivered prematurely in Taiwan. Excessive sputum is a common symptom of respiratory complications in premature infants. Effective methods for reducing sputum secretion in premature infants need to be urgently explored.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 2, 2023

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 11, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2024

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

June 26, 2025

Completed
3 months until next milestone

First Posted

Study publicly available on registry

September 22, 2025

Completed
Last Updated

September 22, 2025

Status Verified

September 1, 2025

Enrollment Period

9 months

First QC Date

June 26, 2025

Last Update Submit

September 16, 2025

Conditions

PreTerm NeonatePulmonary Complications

Keywords

AcupressurePreterm InfantsPulmonary InfiltrationSuction Frequency

Outcome Measures

Primary Outcomes (1)

  • Frequency of sputum suction

    Suctioning frequency per day was obtained from nursing records throughout the intervention period and for the subsequent two days.

    The study outcomes were evaluated before and day 5, day 10, day 12 after the intervention.

Secondary Outcomes (1)

  • Physiological indicatores

    These outcomes were recorded 2 days before the intervention, days 1-5 of the intervention, days 6-10 of the intervention, and 2 days after the intervention.

Study Arms (2)

Acupressure

EXPERIMENTAL
Behavioral: massage acupoints

Routine care

PLACEBO COMPARATOR
Behavioral: Routine care

Interventions

massage acupointsBEHAVIORAL

The massage acupoints involved Zusanli (ST36), Fenglong (ST40), Zhongfu (LU1), Tanzhong (CV17), and Feishu (BL13). Each acupoint was massaged for 2 minutes, totaling 10 minutes per session. The routine care included chest physiotherapy and sputum suction as needed every 3 hours (PRN, Q3H).

Acupressure
Routine careBEHAVIORAL

The routine care included chest physiotherapy and sputum suction as needed every 3 hours (PRN, Q3H).

Routine care

Eligibility Criteria

Age32 Weeks+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Newborn ≤32 weeks of gestational age
  • X-ray reporting pulmonary infiltration requiring suctioning
  • Treated with O2 nasal cannula or High-flow nasal cannula

You may not qualify if:

  • Congenital pulmonary structural abnormalities
  • Muscular weakness
  • Heart disease, excluding Patent Ductus Arteriosus(PDA) and Atrial Septal Defect (ASD)
  • Abnormal bleeding conditions
  • Chest tube placement
  • Compromised skin integrity at the acupressure sites

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Taiwan

Changhua, Taiwan

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 26, 2025

First Posted

September 22, 2025

Study Start

July 2, 2023

Primary Completion

April 11, 2024

Study Completion

June 30, 2024

Last Updated

September 22, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations

TW(1)