NCT00128141

Brief Summary

Two groups of preterm infants with birth weight equal to or less than 1500 grams will be studied. One group will receive the standard care and the other will receive standard care plus maternal special tactile stimulation. Gain of weight, length and head circumference, date of the beginning of enteral feedings, length of time to recover birth weight and age of hospital discharge will be recorded and compared between both groups.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
104

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2003

Typical duration for not_applicable

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

August 1, 2003

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

August 8, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 9, 2005

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2005

Completed
Last Updated

February 5, 2008

Status Verified

February 1, 2008

Enrollment Period

2.3 years

First QC Date

August 8, 2005

Last Update Submit

February 4, 2008

Conditions

Preterm Birth

Outcome Measures

Primary Outcomes (1)

  • length of hospital stay

Secondary Outcomes (2)

  • effect on beginning of enteral feedings

  • growth during hospitalization

Study Arms (2)

1

NO INTERVENTION

2

EXPERIMENTAL

tactile stimulus

Behavioral: Tactile stimulus

Interventions

Tactile stimulusBEHAVIORAL

four times a day

Also known as: massage therapy
2

Eligibility Criteria

Age1 Hour - 3 Days
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Preterm newborns with birth weight equal to or less than 1500 grams and gestational age equal to or less than 32 weeks.
  • Mother willing to participate in study.

You may not qualify if:

  • Major congenital malformations
  • Congenital infectious diseases
  • Mother not willing to participate in study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital de Clínicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, 90035-005, Brazil

Location

MeSH Terms

Conditions

Premature Birth

Interventions

Massage

Condition Hierarchy (Ancestors)

Obstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Intervention Hierarchy (Ancestors)

Therapy, Soft TissueMusculoskeletal ManipulationsComplementary TherapiesTherapeuticsPhysical Therapy ModalitiesRehabilitation

Study Officials

  • Renato S Procianoy, MD

    Universidade Federal do Rio Grande do Sul-Hospital de Clínicas de Porto Alegre

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 8, 2005

First Posted

August 9, 2005

Study Start

August 1, 2003

Primary Completion

November 1, 2005

Study Completion

November 1, 2005

Last Updated

February 5, 2008

Record last verified: 2008-02

Locations

BR(1)