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Early Intervention Program for Preterm Infants and Their Parents: Establishing the Impact at 18 Months Corrected Age

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ClinicalTrials.gov Identifier: NCT02835612
Recruitment Status : Recruiting
First Posted : July 18, 2016
Last Update Posted : February 27, 2019
Sponsor:
Collaborators:
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Bill and Melinda Gates Foundation
Ministry of Health, Brazil
Information provided by (Responsible Party):
Hospital de Clinicas de Porto Alegre

Brief Summary:

There are several intervention programs involving multisensory and motor stimulations such as, gym, auditory, visual, vestibular and tactile stimulations. We propose to study a continuous program of early intervention involving very preterm infants' families in their first 12 months of life taking the chance of their neuronal plasticity during this period. Preterm infants born in our institution will be included when they complete 48 hours after birth (first intervention). All preterm infants and their mothers will be followed during neonatal period and pre hospital discharge they will have a second intervention ( to measure parental bond ). After discharge they will be conducted to follow up program and we will divided all very low birth weight infants included in the study in two groups according previous randomization:

  1. Standard care with motor, and cognition evaluation and intervention according to their needs
  2. Program of early intervention with parents' orientation independently of f the standard evaluation and care that will be performed.

All phases of neurodevelopment will be evaluated, and the parents will be oriented to stimulate motor, language and cognition iteratively and continuously at home; this is a innovative method to improve very preterm neurodevelopment outcome.

Randomization: in neonatal period, preterm infants will be sequentially randomized when they completed 48 hours after birth in:

Group 1- conventional group (CG): standard care, according to the routine care of the NICU (skin-to skin care by mother, kangaroo care ).

Group 2- intervention group (IG): skin-to skin care by mother ( kangaroo care ) plus massage therapy by mothers. They will receive the tactile-kinesthetic stimulation by mothers from randomization until hospital discharge. Intervention performed exclusively by the mothers was based on studies regarding the application of skin stimulations and passive exercises in preterm infants.

Both groups will receive skin-to skin care by mother (Kangaroo Care) according to the routine care of the neonatal intensive care unit (NICU).


Condition or disease Intervention/treatment Phase
Complication of Prematurity Other: Early stimulation Other: Conventional care Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 88 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Early Intervention Program for Preterm Infants and Their Parents: Establishing the Impact at 18 Months Corrected Age
Actual Study Start Date : February 2016
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : July 2021

Arm Intervention/treatment
Experimental: Early stimulation
skin-to skin care by mother (kangaroo care) plus massage therapy by mothers.
Other: Early stimulation
Intervention Group: skin-to skin care by mother ( kangaroo care ) plus massage therapy by mothers. They will receive the tactile-kinesthetic stimulation by mothers from randomization until hospital discharge. Intervention performed exclusively by the mothers was based on studies regarding the application of skin stimulations and passive exercises in preterm infants

Active Comparator: Conventional care
skin-to skin care by mother (kangaroo care).
Other: Conventional care
skin-to skin care by mother, kangaroo care. Standard care, according to the routine care of the NICU.




Primary Outcome Measures :
  1. neurodevelopmental outcome [ Time Frame: one year corrected age ]
    Bayley scales III version


Secondary Outcome Measures :
  1. Mortality [ Time Frame: During NICU hospitalization and follow up program (up to 1 year-old) ]
    Measure by death during hospital stay and the follow at first two years of life

  2. neuromotor outcome [ Time Frame: one year corrected age ]
    AIMS instrument

  3. Parental Bonding [ Time Frame: at hospital discharge and one year corrected age ]
    Parental Bonding Instrument



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Ages Eligible for Study:   up to 7 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Preterm infants born in our institution will be included when they complete 48 hours after birth

Exclusion Criteria:

  • Congenital malformations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02835612


Contacts
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Contact: Rita C Silveira, MD PhD 555198667912 rcsilveira@hcpa.edu.br
Contact: Rita C Silveira, MD PhD

Locations
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Brazil
Hospital de Clinicas de Porto Alegre Recruiting
Porto Alegre, Rio Grande Do Sul, Brazil, 90035903
Contact: Rita Silveira, MD PhD         
Sponsors and Collaborators
Hospital de Clinicas de Porto Alegre
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Bill and Melinda Gates Foundation
Ministry of Health, Brazil
Investigators
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Principal Investigator: Rita C Silveira, MD PhD Hospital de Clínicas de Porto Alegre

Publications of Results:
Other Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Hospital de Clinicas de Porto Alegre
ClinicalTrials.gov Identifier: NCT02835612     History of Changes
Other Study ID Numbers: 150606
150606 ( Registry Identifier: Program for preterm infants )
First Posted: July 18, 2016    Key Record Dates
Last Update Posted: February 27, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided