Objectives: effects of family based intervention on the neurodevelopmental status of preterm neonates.
Study design: Based on parents' consent, some preterm neonates entered as intervention group and some preterm neonates without any intervention entered as the control group.
Inclusion and exclusion criteria: Preterm birth (gestational age<35 weeks) and NICU hospitalizations as inclusion and congenital anomaly was considered as exclusion criteria.
Sample size: 50 neonates in each group.
Intervention: Training sessions for mothers to stimulate skin, hearing and sight senses of neonates daily, performance massage and hydrotherapy and playing with them.
Time of intervention: Training sessions were held every 2 months till 12 months.
primary outcome:Assessment of the family based interventions on the neurodevelopmental status of preterm neonates.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201705079568N17
Registration date:2017-10-02, 1396/07/10
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-10-02, 1396/07/10
Registrant information
Name
Golnaz Rezaeizadeh
Name of organization / entity
Maternal Fetal Neonatal Research Center,Tehran University of Medical Sciences, Tehran, Iran
Country
Iran (Islamic Republic of)
Phone
+98 21 6119 2357
Email address
mfnhrc@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Maternal, Fetal and Neonatal Research Center, Tehran University of Medical Sciences
Expected recruitment start date
2012-03-20, 1391/01/01
Expected recruitment end date
2014-03-21, 1393/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of neuro-developmental status of preterm neonates with and without family based interventions
Public title
Influence of family based intervention on neuro-developmental status of preterm neonates
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Preterm birth (gestational age<35 weeks) and NICU hospitalization.
Exclusion criteria: Congenital anomaly.
Age
To 1 year old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical Sciences
Street address
Ethics committee of Tehran University of Medical Sciences,6 th floor of Tehran University of Medical Sciences,ghods St., Keshavarz blv,Tehran, Iran
City
Tehran
Postal code
Approval date
2012-03-20, 1391/01/01
Ethics committee reference number
1097
Health conditions studied
1
Description of health condition studied
preterm neonates
ICD-10 code
P07
ICD-10 code description
Disorders related to short gestation and low birth weight
Primary outcomes
1
Description
Neuro-developmental status ofneonates
Timepoint
At birth and after 12 months
Method of measurement
Age& Stage Questionnaire (ASQ) and gesell Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Parents' training sessions were held every 2 months for an hour.They should stimulate the skin of their children by massage, stimulate hearing sense by singing and whispering and vision stimulation by colorful cards and toys, hydrotherapy and playing with neonates daily for 45 minutes.
Category
Prevention
2
Description
Neonates in the control group will not receive any spacial intervention except from routine visits.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
NICU,Vali e asr Hospital
Full name of responsible person
Zahra Farahani
Street address
Maternal Fetal and Neonatal research center, Vali e asr Hospital, Imama Khomeini Hospital, Bagher khan Ave., Tehran, Iran
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Maternal fetal neonatal Reseach Center, Tehran University of Medical Sciences