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Table 2 Project Framework: specific objectives, outcomes and period of activities

From: Early intervention program for very low birth weight preterm infants and their parents: a study protocol

Specific Objectives Outcomes Period acticvities
Objective 1:
To implement a program of continuous and global intervention for preterm infants to be delivered by their families Improve interaction parental infants since neonatal period with massage therapy by mothers
Decrease parental stress
Improve neurodevelopment at 12 to 18 months corrected age
During the whole study period.
It start one month after receive the grant. There are meetings with the team during the study. All teamneed to be trained to teach the tactile-kinesthetic stimulation by mothers and home visits. The patients are allocated to the study up to a total of 100 (50 in each group) and sequentially randomized when the patients complete 48 h after birth. Exclusion criteria: congenital malformations and parents’refusing to participate in the study.
At the end professionals with training to carry out the testings for development assessments will provide the results.
Objective 2:
Advise and improve the skills of care givers in respect to children’s needs Reduce to the minimum the lost for follow up (home visits, phone contacts, phone calls)
Decrease parental stress that will be measured previously
Improve parental infant bonding that will be measured in the beginning
Home visits to be sure that the interventions are performed
Patients are randomized to two groups. At admission of the study the intervention will promote a moment of care and further interaction through massage therapy performed by mothers. Following consist of guidelines and measures to promote early intervention with parents’ orientation independently of f the standard evaluation and care that will be performed. There will be daily sessions of 10 to 5 min each one in NICU and three times a week (motor stimulation), daily (cognitive stimulation) at home.
Objective 3:
Evaluate the impact of the intervention in the neurodevelopment of the children More strengthened ties to the program start, as measured by PBI resulting in higher scores of attention, care and protection .
Number of patients with the Bayley III scale normal for corrected age
Number of patients with AIMS scale normal for corrected age.
Statistical measures of the differences between the groups (intervention and conventional approaches).
At discharge of neonatal unit (PBI) we will have the first evaluation. After 10 sessions and home visits we will have the follow up evaluations.
AIMS and Bayley III Scales at 12 to 18 months corrected age
A global neurodevelopment evaluation will be obtained at 12 to 18 months corrected age for all patients.
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