Ignite Creation Date:
2025-12-24 @ 9:44 PM
Ignite Modification Date:
2025-12-25 @ 7:25 PM
Study NCT ID:
NCT07187232
Status:
COMPLETED
Last Update Posted:
2025-09-22
First Post:
2025-06-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effects of Acupressure on Physiological Indicators, Oxygen Demand and Length of Hospital Stay in Premature Infants With Pulmonary Infiltration
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 42}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-07-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2024-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-09-16', 'studyFirstSubmitDate': '2025-06-26', 'studyFirstSubmitQcDate': '2025-09-16', 'lastUpdatePostDateStruct': {'date': '2025-09-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-09-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2024-04-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Frequency of sputum suction', 'timeFrame': 'The study outcomes were evaluated before and day 5, day 10, day 12 after the intervention.', 'description': 'Suctioning frequency per day was obtained from nursing records throughout the intervention period and for the subsequent two days.'}], 'secondaryOutcomes': [{'measure': 'Physiological indicatores', 'timeFrame': '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.', 'description': 'Physiological indicators include heart rate、 respiratory rate、 oxygen saturation.\n\nPhysiological indicators per day was obtained from nursing records throughout the intervention period and for the subsequent two days on physiological chart record sheets.\n\n1. Heart Rate Description: Daily heart rate obtained from nursing records. Unit of measure: beats per minute (bpm). Measured instruments: Philips MX450 ECG Monitor.\n2. Respiratory Rate Description: Daily respiratory rate obtained from nursing records. Unit of measure: breaths per minute. Measured instruments: Philips MX450 ECG Monitor.\n3. Oxygen Saturation (SpO₂) Description: Daily oxygen saturation obtained from nursing records. Unit of measure: percentage (%). Measured instruments: Philips MX450 ECG Monitor.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Acupressure', 'Preterm Infants', 'Pulmonary Infiltration', 'Suction Frequency'], 'conditions': ['PreTerm Neonate', 'Pulmonary Complications']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '32 Weeks', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Newborn ≤32 weeks of gestational age\n* X-ray reporting pulmonary infiltration requiring suctioning\n* Treated with O2 nasal cannula or High-flow nasal cannula\n\nExclusion Criteria:\n\n* Congenital pulmonary structural abnormalities\n* Muscular weakness\n* Heart disease, excluding Patent Ductus Arteriosus(PDA) and Atrial Septal Defect (ASD)\n* Abnormal bleeding conditions\n* Chest tube placement\n* Compromised skin integrity at the acupressure sites'}, 'identificationModule': {'nctId': 'NCT07187232', 'briefTitle': 'Effects of Acupressure on Physiological Indicators, Oxygen Demand and Length of Hospital Stay in Premature Infants With Pulmonary Infiltration', 'organization': {'class': 'OTHER', 'fullName': 'Changhua Christian Hospital'}, 'officialTitle': 'Effects of Acupressure on Physiological Indicators, Oxygen Demand and Length of Hospital Stay in Premature Infants With Pulmonary Infiltration', 'orgStudyIdInfo': {'id': '221235'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Acupressure', 'interventionNames': ['Behavioral: massage acupoints']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Routine care', 'interventionNames': ['Behavioral: Routine care']}], 'interventions': [{'name': 'massage acupoints', 'type': 'BEHAVIORAL', 'description': '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).', 'armGroupLabels': ['Acupressure']}, {'name': 'Routine care', 'type': 'BEHAVIORAL', 'description': 'The routine care included chest physiotherapy and sputum suction as needed every 3 hours (PRN, Q3H).', 'armGroupLabels': ['Routine care']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Changhua', 'country': 'Taiwan', 'facility': 'Taiwan', 'geoPoint': {'lat': 24.0692, 'lon': 120.5512}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Changhua Christian Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}