Complication of Prematurity Clinical Trial
Official title:
Early Intervention Program for Preterm Infants and Their Parents: Establishing the Impact at 18 Months Corrected Age
NCT number | NCT02835612 |
Other study ID # | 150606 |
Secondary ID | 150606 |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | February 2016 |
Est. completion date | July 2021 |
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).
Status | Recruiting |
Enrollment | 88 |
Est. completion date | July 2021 |
Est. primary completion date | December 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A to 7 Days |
Eligibility |
Inclusion Criteria: - Preterm infants born in our institution will be included when they complete 48 hours after birth Exclusion Criteria: - Congenital malformations |
Country | Name | City | State |
---|---|---|---|
Brazil | Hospital de Clinicas de Porto Alegre | Porto Alegre | Rio Grande Do Sul |
Lead Sponsor | Collaborator |
---|---|
Hospital de Clinicas de Porto Alegre | Bill and Melinda Gates Foundation, Conselho Nacional de Desenvolvimento Científico e Tecnológico, Ministry of Health, Brazil |
Brazil,
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, Gonçalves 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. — View Citation
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. — View Citation
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.2012.7 — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | neurodevelopmental outcome | Bayley scales III version | one year corrected age | |
Secondary | Mortality | Measure by death during hospital stay and the follow at first two years of life | During NICU hospitalization and follow up program (up to 1 year-old) | |
Secondary | neuromotor outcome | AIMS instrument | one year corrected age | |
Secondary | Parental Bonding | Parental Bonding Instrument | at hospital discharge and one year corrected age |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT01686685 -
Correlation of CXCR4 Expression in Premature Infants With a Diagnosis of Autism at 24 Months
|
||
Completed |
NCT04494529 -
Single Dose Antenatal Corticosteroids (SNACS) for Women at Risk of Preterm Birth
|
Phase 3 | |
Completed |
NCT02523222 -
Prophylactic Dextrose Gel for Newborns at High-risk for Hypoglycemia
|
N/A | |
Completed |
NCT02632266 -
Effect of Extensively Hydrolyzed Liquid Human Milk Fortifier on Growth and Tolerance in Moderately Premature Infants
|
Phase 4 | |
Completed |
NCT00841295 -
Effects of Parenteral L-carnitine Supplementation in Premature Neonates
|
N/A | |
Recruiting |
NCT05114096 -
Single Dose of Antenatal Corticosteroids for Pregnancies at Risk of Preterm Delivery (SNACS)
|
Phase 4 | |
Completed |
NCT02554630 -
Novel Mechanisms and Approaches to Treat Neonatal Sepsis
|
||
Completed |
NCT01577615 -
Patterned Experience for Preterm Infants
|
N/A | |
Recruiting |
NCT01938261 -
The Preterm Infants' Paracetamol Study
|
Phase 2 |