Clinical trial NCT02835612: Early Intervention Program for Preterm Infants and Their Parents: Establishing the Impact at 18 Months Corrected Age
Official title: Early Intervention Program for Preterm Infants and Their Parents: Establishing the Impact at 18 Months Corrected Age
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Complication of Prematurity
Lead sponsor: Hospital de Clinicas de Porto Alegre
Sponsor class: OTHER
Collaborators: name: Conselho Nacional de Desenvolvimento Científico e Tecnológico
name: Bill and Melinda Gates Foundation
name: Ministry of Health, Brazil
First posted: 2016-07-18
Enrollment: 88
Sex: ALL
Minimum age (years): 48
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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).

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.

To ensure a safe application of the intervention, mothers of the IG will be instructed to observe the newborns' tolerance signs, avoid excessive stimulations, keep the babies lying on their back, with stretched limbs close to the body, and perform the kinesthetic stimulation to one limb at a time. Researchers of our team will have regular meetings with mothers included in IG every 48 hours to assure that they are doing the intervention as instructed and to check the parental bond PARENTAL BONDING INSTRUMENT (PBI) will be applied by a professional blind to the group to which the child belong.

Follow up appointments, home visits and intervention during follow up program The systematic orientation program for early intervention will be according to developmental milestones, anticipating in a month evolutionary step acquisition of motor and / or cognitive expected for corrected age. In the first half of corrected age, the mother, father and / or corresponding caregivers receive simple guidelines to encourage large motor skills, fine and cognition.

The time of these activities must not exceed 15 minutes and must seem game.Three times / week (alternating with gross and fine motor stimulation).

We will be perform two orientations every three months for cognitive stimulation, fine and gross motor , totaling the 10 home visits promoting guidance and supervision sessions. Systematic orientations will be delivered to parents in all medical appointments at follow up clinic.

There will be home visits in order to evaluate the comprehension of the orientation and to be sure that the intervention has been done by families.

There will be a multidisciplinary team involved in the whole study and we will have a critical view of the intervention impact (final evaluation) in both; conventional and intervention groups.

The infants will be evaluated in relation to their motor, and cognitive neurodevelopment using AIMS and Bayley III scales between 12 and 18 months corrected age.

AIMS (Alberta Motor Infant Scale): a blinded physiotherapist will evaluate the children of both groups between 12 and 18 months with Alberta Infant Motor (AIMS) scale in all eligible patients.

A global evaluation will be performed at one year chronological age with Bayley and AIMS scales.

The evaluation will be conducted in the presence of parents or caregivers in a safe surface with room for the child move around during the evaluation. The examiner will interact with the child to encourage response, but physical facilitation of movement should be avoided. During the evaluation, they are punctuated behaviors more or less mature within the motor repertoire of the child in each position (supine, prone, sitting and standing). This repertoire is called "motor" window. All items priced within the window motor and the window motor to the previous items are scored. The evaluation of the end, the child will receive a score based on the sum of the items scored on each posture, called raw score. This score will be observed in a standardized chart to find the baby development percentile according to the chronological age or corrected. Percentiles instrument standards are: 5%, 10%, 25%, 50%, 75%. According to this percentile baby's development can be classified into three categories: normal or typical (percentile\> 25%), suspicious (BSDI-III: Bayley Scales of Infant and Toddler Development third edition: The Bayley Scales of Infant and Toddler Development, Third Edition, will be used for assessment of neurodevelopment at 12 and 18 months' corrected age. The scales will be administered at the hospital clinic, on the same day of each follow-up visit, by a psychologist who was blinded to group allocation. Cognitive, motor, and language development will be considered normal if higher than 89; below average if 80 to 89; borderline if 70 to 79; and extremely low if less or equal 69. Examine all the facets of a young child's development according manual.

AIMS and Bayley Scales are recommended to use together and a different ages because false positives are common and therefore it is beneficial to follow-up children at high risk of motor impairment at more than one time point, or to use a combination of assessment tools.

If this program shows a good result it can be expanded for the whole preterm population in order to improve their neurodevelopment outcome.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Congenital malformations

Primary outcomes:
measure: neurodevelopmental outcome
timeFrame: one year corrected age
Secondary outcomes:
measure: Mortality
timeFrame: During NICU hospitalization and follow up program (up to 1 year-old)
measure: neuromotor outcome
timeFrame: one year corrected age
measure: Parental Bonding
timeFrame: at hospital discharge and one year corrected age
Other outcomes:
Locations:
city: Porto Alegre
country: Brazil
facility: Hospital de Clinicas de Porto Alegre
state: Rio Grande Do Sul
Study officials:
affiliation: Hospital de Clínicas de Porto Alegre
name: Rita C Silveira, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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.2012.732. No abstract available.
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.
citation: 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.