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IRCT20210224050479N1 IRCT 2021-03-03 Mashhad University of Medical Sciences Comparative Study of the Effect of Oral Stimulation and Non-Oral Stimulation Intervention in Premature Infant on start time, the Time of Independent Oral Nutrition, Weight Gain and length of stay in hospital Comparative Study of the Effect of Oral Stimulation and Non-Oral Stimulation Intervention in Premature Infant on start time, the Time of Independent Oral Nutrition, Weight Gain and length of stay in hospital 2021-02-28 anticipated 90 Complete https://irct.ir/trial/54544 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Other, Purpose: Supportive, Randomization description: It was used to allocate infants to intervention and control groups by random block method with a volume of 3 (numbers 1 to 90) according to the lottery in closed envelopes. Random block sampling is a method of randomization that ensures that at almost every point in a study, an almost equal number of participants are assigned to all comparison groups, Blinding description: The analyst will be unaware of the intervention and control groups. N/A The study is about premature infants and the importance of achieving independent oral nutrition and weight gain.. Intervention 1: Intervention group: Oral stimulation group with PIOMI method: "Oral stimulation before feeding" program is a five-minute oral-motor intervention. In this program, stimuli are applied to oral structures including cheeks, gums, lips, tongue. It is served by gavage once a day before feeding. Oral ostomy intervention for 7 consecutive days without interruption for each infant is performed first by the researcher and after education to the mother by the mother. The 5-minute stimulation program includes 3 minutes of stretching and cheek massage and 2 minutes (non-nutritional sucking (NNS)). Intervention 2: Intervention group: Non-oral stimulation group with FIELD technique is another group that will be performed by field field massage method per day. Each 15-minute period (before feeding) consists of three 5-minute phases in which the infant is placed in a supine position on the abdomen at the beginning and end, and the fingers of both hands are touched with a gentle pressure with the smooth part of the fingers. In these two phases, one of the following five areas is touched every minute (12 touches in 5 seconds): from the tip of the head down to the sides of the face to the neck and vice versa, ‌ from the back of the neck across the shoulders and vice versa , From the upper back to the bottom to the waist and vice versa, from the thighs down to the ankles and vice versa, from the shoulders to the wrists and vice versa. In the middle phase, the infant was lying flat on its back and 6 passive extension-flexion movements (one every 10 seconds) were given to these five areas, respectively: right arm, left arm, right leg, left leg, and both legs. This protocol lasts for 7 days. Intervention 3: Control group: NICU routine care including non-nutritional sucking and kangaroo care will be given to the baby twice a day. Yes - There is a plan to make this available What will be shared: Publish as an article When: After publishing the article To whom: Researchers working in academic institutions Conditions: Use of data and results with reference Where to obtain: Correspondence with the project manager Dr. Naghmeh Razaghi How to obtain: Request via email Comments:
public Dr Naghme Razaghi
Doktora crossroad
Mashhad Iran (Islamic Republic of) 91778-99191 +98 51 3859 1513 RazaghiN@mums.ac.ir Mashhad University of Medical Sciences scientific Najme Zabihi Torbati
Emamt46-N:60/1
Mashhad Iran (Islamic Republic of) 3246599002 +98 51 3602 5721 Zabihitn1@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) 1. Be born between 28 and 32 weeks of gestation.2. Receive nutrition through the tube3. Their birth weight is between 1000-2000 grams4. Have physiological stability (stability in spo2, Hr, RR) at the beginning of nutritional stimulation.5. Oral stimulation and the onset of feeding in these infants do not alter the autonomic system [skin color, heart rate, or respiration rate].6. Apgar score above 6 in 5 minutes7. Newborns without congenital anomalies and obvious chromosomal abnormalities8. No oral lesions such as candidiasis9. No lip and mouth abnormalities such as cleft lip and palate no limit no limit Both 1. NPO of the baby in case of symptoms such as fever, respiratory distress, muscle stiffness, frequent vomiting for one day and more2. Diagnosis of cases such as intraventricular hemorrhage, necrotizing enterocolitis, open arterial duct, sepsis, acute lung disease or severe anemia by a physician during the days of interventions3. The need for surgery during the days of interventions4. Transfer the baby to other centers5. Infant death6. Lack of cooperation of the mother in performing the interventions7. Maternal addiction8. Physiological instability (spo2, Hr, RR) during a day and night so that he can not receive one pumice massage or two field massage. p07 اختلالاتی که به کوتاه بودن دوران حاملگی یا وزن کم زمان تولد مربوط باشد Rehabilitation Rehabilitation N/A Intervention group: Oral stimulation group with PIOMI method: "Oral stimulation before feeding" program is a five-minute oral-motor intervention. In this program, stimuli are applied to oral structures including cheeks, gums, lips, tongue. It is served by gavage once a day before feeding. Oral ostomy intervention for 7 consecutive days without interruption for each infant is performed first by the researcher and after education to the mother by the mother. The 5-minute stimulation program includes 3 minutes of stretching and cheek massage and 2 minutes (non-nutritional sucking (NNS)). Intervention group: Non-oral stimulation group with FIELD technique is another group that will be performed by field field massage method per day. Each 15-minute period (before feeding) consists of three 5-minute phases in which the infant is placed in a supine position on the abdomen at the beginning and end, and the fingers of both hands are touched with a gentle pressure with the smooth part of the fingers. In these two phases, one of the following five areas is touched every minute (12 touches in 5 seconds): from the tip of the head down to the sides of the face to the neck and vice versa, ‌ from the back of the neck across the shoulders and vice versa , From the upper back to the bottom to the waist and vice versa, from the thighs down to the ankles and vice versa, from the shoulders to the wrists and vice versa. In the middle phase, the infant was lying flat on its back and 6 passive extension-flexion movements (one every 10 seconds) were given to these five areas, respectively: right arm, left arm, right leg, left leg, and both legs. This protocol lasts for 7 days Control group: NICU routine care including non-nutritional sucking and kangaroo care will be given to the baby twice a day. The timing of the onset of oral feeding in infants in the intervention and control groups will be assessed. Timepoint: When to start oral feeding for the first time. Method of measurement: Record the age of the infant at the time of starting oral feeding in a questionnaire. The time of reach to independent oral feedings in the infants of the intervention and control groups will be evaluated. Timepoint: Time to reach 8 times independent oral feeding. Method of measurement: Record the age of the infant at the time of reaching 8 times of independent oral feeding in a questionnaire. The weight of the newborns will be assessed on a daily basis and the average will be compared in the intervention and control groups. Timepoint: The weight during the study on a daily. Method of measurement: Weight will measure with scales. The age of hospital discharge in infants in the intervention and control groups will be compared. Timepoint: The time of discharge. Method of measurement: Record the age of the infant at the time of discharge in a questionnaire. Mashhad University of Medical Sciences Approved 2021-01-28 Ethics Committee of Mashhad University of Medical Sciences Doktora Crossroads-School of Nursing and Midwifery mashhad Razavi Khorasan Iran (Islamic Republic of)