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IRCT2016060628295N1 IRCT 2017-01-28 Vice Chancellor For Research, Mashhad University Of Medical Sciences Effect of pacifier in preterm infant 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. 2016-01-21 anticipated 76 Complete https://irct.ir/trial/22978 interventional Randomization: Not randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, 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. N/A Feeding tolerance and physiologic criteria in preterm infants. Intervention 1: 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. Intervention 2: Control group:infants in control group just take routine care and didn't received pacifier.every 6 hour,we filled the checklist for them.
public Parisa Rahnama
Daneshgah Street
Mashhad Iran (Islamic Republic of) +98 51 3859 1511 rahnamap2@mums.ac.ir Mashhad university of medical science scientific Mohammad Heidarzadeh
Ministry of Health and Medical Education
Tehran Iran (Islamic Republic of) - +98 915 615 5537 heidarzadeh_2013@yahoo.com Neonata lHealth Office Iran (Islamic Republic of) 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. no limit 31 days Both P07 Disorders related to short gestation and low birth weight, not elsewhere classified N/A N/A 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. Control group:infants in control group just take routine care and didn't received pacifier.every 6 hour,we filled the checklist for them. Physiologic criteria including Heart rate, respiratory rate and o2 saturation. Timepoint: every 6 Hour. Method of measurement: with pulse oxymetery and counting respiratory rate. 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. _. Timepoint: _. Method of measurement: _. Vice Chancellor For Research, Mashhad University Of Medical Sciences Approved 2016-01-16 Ethics Committee Of Mashhad University Of Medical Science Daneshgah Street Mashhad Iran (Islamic Republic of)