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

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).

Conditions

• Complication of Prematurity

Interventions

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

OTHER

Conventional care

skin-to skin care by mother, kangaroo care. Standard care, according to the routine care of the NICU.

Sponsors & Collaborators

• Conselho Nacional de Desenvolvimento Científico e Tecnológico

  collaborator OTHER_GOV

• Bill and Melinda Gates Foundation

  collaborator OTHER

• Ministry of Health, Brazil

  collaborator OTHER_GOV

• Hospital de Clinicas de Porto Alegre

  lead OTHER

Principal Investigators

• Rita C Silveira, MD PhD · Hospital de Clínicas de Porto Alegre

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

48 Hours

Max Age

7 Days

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2016-02-29

Primary Completion

2020-12-31

Completion

2021-12-31

Countries

• Brazil

Study Locations