Clinical Trial of Effect of Pacifier on physiologic criteria and feeding tolerance in preterm infant According to the NHS(national health system) Guideline of NNS.
Aim: Effect of pacifier on physiologic criteria and feeding tolerance in preterm infants.
In this Clinical trial, 76 preterm infants Weighing 1500 gr or less and gestational age was 32 weeks and less, selected (if they have including criteria) and divided into two groups of 38 intervention and control groups. Infants in the control group received routine care but the infants in the intervention group received pacifier 10 minutes before feeding, during and after feeding as long as the infant is not willing to suck a pacifier. According to the National Health Service guideline of nonnutritive sucking, it repeated in every feeding time. Pacifier didn’t push into the infant's mouth by force, but first gently touch the lips and around the infant’s mouth. If opened his mouth put a pacifier into the mouth and on the tongue. To keep the pacifier brought the infant to his mouth to hold a pacifier or the researcher was kept quiet. For both groups list of feeding tolerance including residue, distension, vomiting and defecation were completed 4 times in 24 hours. The intervention lasted for 20 days and the two groups were compared using statistical analysis.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016060628295N1
Registration date:2017-01-28, 1395/11/09
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-01-28, 1395/11/09
Registrant information
Name
Parisa Rahnama
Name of organization / entity
Mashhad University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 51 3859 1311
Email address
rahnamap2@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research,Mashhad University of Medical Science
Expected recruitment start date
2016-01-21, 1394/11/01
Expected recruitment end date
2016-08-21, 1395/05/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical Trial of Effect of Pacifier on physiologic criteria and feeding tolerance in preterm infant According to the NHS(national health system) Guideline of NNS.
Public title
Effect of pacifier in preterm infant
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: Gestational age between 26 to 32 weeks according to the Ballard scale; Age of birth up to 48 hours; birth weight less than 1500 g; no previous feeding (Along with the study, tube feeding for the infant begins); Lack of respiratory distress requiring intubation and ventilator; Lack of asphyxia; Lack of mother addiction; Having first and the fifth minute Apgar score above 7; No anomaly of the jaw, mouth and gastrointestinal tract like cleft lip, cleft palate and Esophageal atresia. Exclusion criteria: Feeding intolerance and NPO during the study; The need for intubation during study; The incidence of NEC during the study; Intraventricular hemorrhage (grade 3 and 4); Hospital Stay less than 7 days; Sepsis during the study; The reluctance of parents to continue to participate in the study.
Age
To 31 days old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
76
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
With sortition between two groups,first group was determined.Sampling was started at control group and when it was finished,the intervention group was sampled. Oral feeding disruption,sepsis and intracranial haemorrhage caused the infant out of study.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee Of Mashhad University Of Medical Science
Street address
Daneshgah Street
City
Mashhad
Postal code
Approval date
2016-01-16, 1394/10/26
Ethics committee reference number
research/940959/1/920
Health conditions studied
1
Description of health condition studied
Feeding tolerance and physiologic criteria in preterm infants
ICD-10 code
P07
ICD-10 code description
Disorders related to short gestation and low birth weight, not elsewhere classified
Primary outcomes
1
Description
Physiologic criteria including Heart rate, respiratory rate and o2 saturation
Timepoint
every 6 Hour
Method of measurement
with pulse oxymetery and counting respiratory rate
2
Description
feeding tolerance including vomiting, residue,abdominal distension and defecation
Timepoint
every 6 Hour(6,12,18,24)
Method of measurement
Observation and complete the checklist
Secondary outcomes
1
Description
_
Timepoint
_
Method of measurement
_
Intervention groups
1
Description
infants in intervention group recieved pacifier according to the NNS guidline 10 minute before feeding,during and after feeding until the infant wants to suck the pacifier.The pacifier was used in this trial,was spesify for premature infants and manufactored by Philips company in Germany and it is only for hospital use.
Category
N/A
2
Description
Control group:infants in control group just take routine care and didn't received pacifier.every 6 hour,we filled the checklist for them.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Omolbanin Hospital
Full name of responsible person
Parisa Rahnama
Street address
Ayatollah Behjat 16, Ayatollah Behjat Street
City
Mashhad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor For Research, Mashhad University Of Medical Sciences
Full name of responsible person
Tayebeh Reyhani
Street address
Daneshgah street
City
Mashhad
Grant name
-
Grant code / Reference number
-
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor For Research, Mashhad University Of 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
Mashhad university of medical science
Full name of responsible person
Parisa Rahnama
Position
Master student of Neonatal Intensive Care nursing
Other areas of specialty/work
Street address
Daneshgah Street
City
Mashhad
Postal code
Phone
+98 51 3859 1511
Fax
+98 51 3859 1511
Email
rahnamap2@mums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Neonata lHealth Office
Full name of responsible person
Mohammad Heidarzadeh
Position
Assistant Professor
Other areas of specialty/work
Street address
Ministry of Health and Medical Education
City
Tehran
Postal code
-
Phone
+98 915 615 5537
Fax
+98 914 315 0498
Email
heidarzadeh_2013@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University Of Medical Sciences
Full name of responsible person
Parisa Rahnama
Position
Master student of Neonatal Intensive Care nursing
Other areas of specialty/work
Street address
Daneshgah street
City
Mashhad
Postal code
Phone
+98 51 3859 1511
Fax
+98 51 3859 1511
Email
rahnamap2@mums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)