Early Intervention Program for Preterm Infants and Their Parents: Establishing the Impact at 18 Months Corrected Age
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 138
- Locations
- 1
- Primary Endpoint
- Change in neurodevelopmental outcome
Study Overview
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:
- Standard care with motor, and cognition evaluation and intervention according to their needs
- 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).
Detailed Description
The main Goal is to develop a program of early intervention for very preterm infants that allows families to apply it continuously at home. An additional objective of this research is to quantify the results of early stimulation on improvement of cognition and motor skills.
Introduction- Born prematurely (soon to born) and its consequences cause major impact on society and health indicators of population. According to the 2012 ''Born Too Soon: The Global Action Report on Preterm Birth'' of the World Health Organization, Brazil is ranked 10th among the countries with the highest number of preterm live births and 16th in deaths due to complications of prematurity. The data from 2012 indicate that approximately 3 million babies are born in Brazil each year, 350 000 of whom are born with less than 37 weeks of gestation, and born prematurity index is higher in the last three years, including preterm very low birth weight infants gestational age (GA) less than 32 weeks and birth weight less than 1500 grams). More than half of the preterm infants with birth weight less than 1500 grams born in public university centers of Brazilian Neonatal network Research at a gestational age of 23-33 weeks died or were discharged with severe pulmonary, neurological or ophthalmological complication.
Early intervention for high risk preterm infant must focus in the parents-infant relationship, environment and behavioral attitudes. It is possible that a care process modified by households is beneficial for neurodevelopment premature, both in the cognitive aspect as motor.
Background Preterm infants are high risk for delayed neurodevelopment. Early intervention programs for preterm infants that focus on development while the babies are still in the hospital and post discharge from the hospital, and into the community setting may have a greater impact on long-term morbidity as they are able to focus more on family factors and the home environment. Interventions that are aimed at enhancing the parent-infant relationship focus on sensitizing the families to infants cues and teach appropriate and timely response to the preterm infant's needs, possibly that early high-quality parent-infant or mother-infant interactions positively influence cognitive and social development in children. Despite of those evidences, the role of the family applying those programs at home is not well studied especially in social deprived environments.
The groups and randomization according previous information in summary. In the NICU both groups will receive skin-to skin care by mother (Kangaroo Care) according to the routine care of the NICU, The mothers will be instructed to perform one stage at a time, and will be supposed to end the sequence within 15 min, four times per day with an interval of 6 hours.The tactile stimulation will be performed on the cutaneous surface and the muscular area corresponding to the temporal, frontal, periorbital, nasal and perilabial regions of the face; the external side of the upper and lower limbs; and the soft parts of two or three fingers grouped will be passed gently with moderate pressure, up to three times in one direction and three times in the opposite direction. The kinesthetic stimulation will consist of passive exercises (flexion and extension) of upper and lower limbs, one limb at a time and up to three times at each articulation (wrist, elbow, ankle and knee); one of the hands supporting the stimulated limb and the other hand performing the movements.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Double (Investigator, Outcomes Assessor)
Masking Description
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)
Eligibility Criteria
- Ages
- 48 Hours to 7 Days (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Preterm infants born in our institution will be included when they complete 48 hours after birth
Exclusion Criteria
- •Congenital malformations
Arms & Interventions
Early stimulation
skin-to skin care by mother (kangaroo care) plus massage therapy by mothers.
Intervention: Early stimulation (Other)
Conventional care
skin-to skin care by mother (kangaroo care).
Intervention: Conventional care (Other)
Outcomes
Primary Outcomes
Change in neurodevelopmental outcome
Time Frame: 4 months, 8 months 12 months and 18 months corrected age,
Bayley scales III version
Secondary Outcomes
- 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)
