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

NCT02835612 | Completed

• 1 other identifier: 150606
• Study Type: interventional
• Target: 138
• Locations: 1 country
• Sites: 1

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

Conditions

Complication of Prematurity

Outcome Measures

Primary Outcomes (1)

• Change in neurodevelopmental outcome

  Bayley scales III version

  4 months, 8 months 12 months and 18 months corrected age,

Secondary Outcomes (4)

• Mortality

  During NICU hospitalization and follow up program (up to 18 months CA)

• neuromotor outcome

  one year corrected age

• home environment and maternal practices

  one year corrected age

• Child/Mother interactions

  12 months corrected age

Other Outcomes (1)

• Parent-Led Early Intervention in Very Preterm Infants: Effect on Executive Function at School Age

  At school age.

Study Arms (2)

Early stimulation

EXPERIMENTAL

skin-to skin care by mother (kangaroo care) plus massage therapy by mothers.

Other: Early stimulation

Conventional care

ACTIVE COMPARATOR

skin-to skin care by mother (kangaroo care).

Other: Conventional care

Interventions

Early stimulation OTHER

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

Early stimulation

Conventional care OTHER

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

Conventional care

Eligibility Criteria

• Age: 48 Hours - 7 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• Congenital malformations

Sponsors & Collaborators

• Hospital de Clinicas de Porto Alegre: lead
• Conselho Nacional de Desenvolvimento Científico e Tecnológico: collaborator
• Bill and Melinda Gates Foundation: collaborator
• Ministry of Health, Brazil: collaborator

Study Sites (1)

Hospital de Clinicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, 90035903, Brazil

Location

Related Publications (6)

• Guinsburg R, de Almeida MF, de Castro JS, Silveira RC, Caldas JP, Fiori HH, do Vale MS, Abdallah VO, Cardoso LE, Alves Filho N, Moreira ME, Acquesta AL, Ferrari LS, Bentlin MR, Venzon PS, Goncalves Ferri WA, Meneses Jdo A, Diniz EM, Zanardi DM, Dos Santos CN, Bandeira Duarte JL, Rego MA. Death or survival with major morbidity in VLBW infants born at Brazilian neonatal research network centers. J Matern Fetal Neonatal Med. 2016 Mar;29(6):1005-9. doi: 10.3109/14767058.2015.1031740. Epub 2015 Apr 2.

  PMID: 25812674 BACKGROUND

• Silveira RC, Filipouski GR, Goldstein DJ, O'Shea TM, Procianoy RS. Agreement between Bayley Scales second and third edition assessments of very low-birth-weight infants. Arch Pediatr Adolesc Med. 2012 Nov;166(11):1075-6. doi: 10.1001/archpediatrics.2012.732. No abstract available.

  PMID: 23007841 RESULT

• Procianoy RS, Mendes EW, Silveira RC. Massage therapy improves neurodevelopment outcome at two years corrected age for very low birth weight infants. Early Hum Dev. 2010 Jan;86(1):7-11. doi: 10.1016/j.earlhumdev.2009.12.001. Epub 2009 Dec 22.

  PMID: 20022717 RESULT

• Silveira RC, Valentini NC, O'Shea TM, Mendes EW, Froes G, Cauduro L, Panceri C, Fuentefria RN, Procianoy RS. Parent-Guided Developmental Intervention for Infants With Very Low Birth Weight: A Randomized Clinical Trial. JAMA Netw Open. 2024 Jul 1;7(7):e2421896. doi: 10.1001/jamanetworkopen.2024.21896.

  PMID: 39018071 RESULT

• Silveira RC, Mendes EW, Fuentefria RN, Valentini NC, Procianoy RS. Early intervention program for very low birth weight preterm infants and their parents: a study protocol. BMC Pediatr. 2018 Aug 9;18(1):268. doi: 10.1186/s12887-018-1240-6.

  PMID: 30092772 RESULT

• Tarouco ML, Procianoy RS, O'Shea TM, Silveira RC. Parent-Led Early Intervention in Very Preterm Infants and Executive Function at School Age: Secondary Analysis of a Randomized Clinical Trial. JAMA Pediatr. 2026 Jan 20:e255866. doi: 10.1001/jamapediatrics.2025.5866. Online ahead of print.

  PMID: 41557341 DERIVED

Study Officials

• Rita C Silveira, MD PhD

  Hospital de Clínicas de Porto Alegre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: IN THE NICU, intervention group received skin-to-skin care performed by the mother (kangaroo care) plus tactile-kinesthetic stimulation, also performed by the mothers, beginning at randomization, and continuing until hospital discharge. Infants in the Conventional Group (CG) received kangaroo care according to the routine of the NICU. After hospital discharge, we provided the cognitive-motor home-based intervention for infants in the IG and a home-based support protocol for all caregivers and parents. The principal investigators and the outcomes assessors didnt have known about the group that allocated patients and families (masked)
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: we followed the SPIRIT 2013 statement. The research was approved by the hospital research committee. When infants reached 48 postnatal hours, they are sequentially randomized to the Enhanced Developmental Intervention (EDI) or Intervention Group or Usual Care or Conventional group (CG) using block randomization in a computer system (http://biostat.mc.vanderbilt.edu/wiki/Main/BlockRandomizationWithRandomBlockSizes). After the randomization, the intervention was initiated on the 7th postnatal day in the NICU (Neonatal Intensive Care Unit)

Study Record Dates

• First Submitted: July 11, 2016
• First Posted: July 18, 2016
• Study Start: February 1, 2016
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2021
• Last Updated: November 28, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)