Effectiveness of non-nutritive sucking performed by the mother on the physiological indexes and full oral feeding in premature infants in the neonatal intensive care unit
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This research is randomized clinical trial . The research does for 40 neonates in two groups. The goal is the effect of non-nutritive sucking by the mother on the physiological stability and full oral feeding in premature infants. Neonates have 1000-2500 gr weight and 26-34 weeks age of pregnancy. Mothers do intervention with stimulate that neonate suck mother's finger. ،This intervention does 3times in a day(24 hours).physiological sign (breath, heart,O2 Sat)measure in 5 min before, during and 5 min after intervention with pulsoxymetry. In additional amount of milk that be gavage during of intervention had measured. This intervention does until neonate can feed with complete oral feeding.
General information
Acronym
nns
IRCT registration information
IRCT registration number:IRCT201501205163N2
Registration date:2015-06-10, 1394/03/20
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-06-10, 1394/03/20
Registrant information
Name
Akram sadat Sadat hoseini
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6653 2998
Email address
ashoseini@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2015-01-22, 1393/11/02
Expected recruitment end date
2015-08-20, 1394/05/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effectiveness of non-nutritive sucking performed by the mother on the physiological indexes and full oral feeding in premature infants in the neonatal intensive care unit
Public title
Effectiveness of non-nutritive sucking performed by the mother on the physiological indexes and full oral feeding in premature infants in the neonatal intensive care unit
Purpose
Supportive
Inclusion/Exclusion criteria
inclusion criteria: neonate: age of pregnancy 26-34 weeks; weight 1000-2500gr; score of apgar in 1 &5 minuets were above 7; was normal without congenital & respiratory and heart disease; have not respiratory assistant; do no use any drug can effect on respiratory and nervous system; not use other kind of complementary care; have normal physiologic sign
mother: do not use drug or alcohol; can do two intervention a day; has not scare in finger
Exclusion criteria: Mother does not want to do intervention; neonate can not tolerate intervention or will change situation
Age
From 1 day old to 2 months old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
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
Tehran University Medical Sciences
Street address
Qudes St - Keshavarz Bol
City
Tehran
Postal code
1473656169
Approval date
2015-01-14, 1393/10/24
Ethics committee reference number
93-04-28-27919
Health conditions studied
1
Description of health condition studied
complete breast feeding
ICD-10 code
P92.8
ICD-10 code description
Other feeding problems of newborn
Primary outcomes
1
Description
Phisiologic signs
Timepoint
Before/during/after intervention
Method of measurement
pulsoximetry
2
Description
vital signe
Timepoint
before/ after and during of trial
Method of measurement
pals oximetry
Secondary outcomes
1
Description
complete feeding through mouth
Timepoint
when order the physition
Method of measurement
with C.C of feeding
2
Description
Oral feeding
Timepoint
ordered by physician
Method of measurement
c.c milk
Intervention groups
1
Description
control: Rotine nursing intervention
Category
Rehabilitation
2
Description
intervention: Non nutrition sucking buy sucking of mother's finger
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Tehran university medical sciences
Full name of responsible person
Akram sadat sadat hoseini
Street address
Tohid squire- faculty of nursing and midwifery
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University Medical Sciences
Full name of responsible person
Mohammad Ali Cheraghi
Street address
Faculty of nursing and midwifery- Tohid squire
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Tehran University Medical Sciences
Full name of responsible person
Akram sadat Sadat Hoseini
Position
PhD/Assisstant professore
Other areas of specialty/work
Street address
Faculty of nursing and midwifery- Tohid squire
City
Tehran
Postal code
1473656169
Phone
+98 21 6105 4423
Fax
Email
ashoseini@tums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University Medical Sciences
Full name of responsible person
Akram sadat Sadat Hoseini
Position
PhD/assisstance professore
Other areas of specialty/work
Street address
Faculty of nursing and midwifery- Tohid squire
City
Tehran
Postal code
1473656169
Phone
+98 21 6105 4423
Fax
Email
ashoseini@tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran University Medical Sciences
Full name of responsible person
Akram sadat Sadat Hoseini
Position
PhD/ assisstance professore
Other areas of specialty/work
Street address
Faculty of nursing and midwifery- Tohid squire
City
Tehran
Postal code
1473656169
Phone
+98 21 6105 4423
Fax
Email
ashoseini@tums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)