Non-nutritive sucking with pacifier and finger on weight gaining, initiation of breastfeeding and discharge of preterm newborns, in neonatal intensive care unit, Hazrat Zynab hospital, Shiraz
Objectives: Infants born prematurely are vulnerable. Many premature infants because of in coordination between sucking, swallowing and breathing, may need alternative feeding methods, until the development of skills which necessary for oral feeding. Design: 3 groups, single blind randomized control trial. Setting and conduct: Neonatal intensive care unit (NICU) of one university hospital in Shiraz city. Participants: 90 healthy preterm newborns, Fetal age between 30-34 weeks; Birth weight appropriate for gestational age(AGA); Apgar score at 1 and 5 min after birth ≥ 7; Non addicted mothers; No need for phototrapy; No need for complete parental feeding, will randomly assigned to three groups: two experimental groups and control group and will Excluded if Un willingness the parents for complete the study; Need for transfer to other wards or other hospitals; Received drugs that affect central nerves system; Need for surgical and medical interventions during study; Need for photo therapy during study; Received other supportive intervention; Abnormal physiologic response during intervention; Missing of intervention at least twice during study.
Intervention: Non-nutritive sucking with finger and pacifier that will be carried out by mothers in 10 first minuets of gavages' feeding, three times a day. Main outcome: Neonate’s weight will be evaluated daily by trained midwife until discharge day, also the initiation of breast feeding and the time of discharge will be recorded.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201106062324N8
Registration date:2012-03-17, 1390/12/27
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2012-03-17, 1390/12/27
Registrant information
Name
Maryam Keshavarz
Name of organization / entity
Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 4365 1813
Email address
keshavarz@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
vice chancellor for research- Tehran University of Medical Sciences
Expected recruitment start date
2011-10-23, 1390/08/01
Expected recruitment end date
2012-03-20, 1391/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Non-nutritive sucking with pacifier and finger on weight gaining, initiation of breastfeeding and discharge of preterm newborns, in neonatal intensive care unit, Hazrat Zynab hospital, Shiraz
Public title
The impact of non-nutritive sucking with pacifier and finger on weight gaining, initiation of breastfeeding and discharge of preterm newborns.
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Fetal age between 30-34 weeks; Birth weight appropriate for gestational age(AGA)); Apgar score at 1 and 5 min after birth, ≤ 7; Normal neonate (no evidence of congenital anomaly such as respiratory and heart problems, seizure, CNS hemorrhage …); Non addicted mothers; No need for phototherapy; No need for complete parental feeding. Exclusion criteria: Un willingness the parents for complete the study; Need for transfer to other wards or other hospitals; Received drugs that affect central nerves system for example: Phenobarbital and phenytoin; Need for surgical and medical interventions during study; Need for photo therapy during study; Received other supportive intervention such as touch therapy, kangaroo care, music therapy and other intervention during study; Abnormal physiologic response such as heart rate above 200 beat per min or under 100 beat per min, deceleration of oxygen saturation level under 80% during intervention; Missing of intervention at least for two times during study.
Age
To 1 year old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
1
Registry name
No
Secondary trial Id
No
Registration date
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethical commitment of Tehran University of Medical Sciences