NCT03061968

Brief Summary

The purpose of this study is to investigate the effects of acupressure application in very low birth weight premature.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2010

Longer than P75 for not_applicable

Status
unknown

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

May 1, 2010

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

January 12, 2011

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
5.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2017

Completed
22 days until next milestone

First Posted

Study publicly available on registry

February 23, 2017

Completed
Last Updated

February 24, 2017

Status Verified

February 1, 2017

Enrollment Period

1.6 years

First QC Date

January 12, 2011

Last Update Submit

February 22, 2017

Conditions

Premature

Keywords

acupressurevery-low- birth-weight prematurebody weightbehavioral statedevelopmental status

Outcome Measures

Primary Outcomes (1)

  • Body Weight

    The data will be collected by a self-developed structured questionnaire, including: 1) demographic data of premature; 2)body weight every day until discharge.

    15 days.

Study Arms (2)

experimental group

EXPERIMENTAL

The babies in experimental group will be observed for one day, and then intervene the simplified acupressure three times a day for fifteen days, and continuously recoding the observation and records until discharge.

Behavioral: acupressure

control group

NO INTERVENTION

The control group only receive routine care in sick baby room unite.

Interventions

acupressureBEHAVIORAL

The babies in experimental group will be observed for one day, and then intervene the simplified acupressure three times a day for fifteen days, and continuously recoding the observation and records until discharge.

experimental group

Eligibility Criteria

AgeUp to 37 Weeks
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • according to the criteria of very low birth weight (\<1500gm) from a sick baby room in a medical center.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Premature BirthBody Weight

Interventions

Acupressure

Condition Hierarchy (Ancestors)

Obstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapy, Soft TissueMusculoskeletal ManipulationsComplementary TherapiesTherapeuticsPhysical Therapy ModalitiesRehabilitation

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 12, 2011

First Posted

February 23, 2017

Study Start

May 1, 2010

Primary Completion

December 1, 2011

Study Completion

February 1, 2017

Last Updated

February 24, 2017

Record last verified: 2017-02

Data Sharing

IPD Sharing
Will not share