The Effect of Elastic Sac on Feeding
Condition: Oxygen Saturation; Heart Rate; Nutritional Status
Study type: Interventional

Summary: 
      The study will be conducted using the crossover randomized controlled method. Preterm infants
      who began oral feeding from the neonatal intensive care unit will be divided into two groups
      through randomization in the computer environment. Following the randomization, infants in
      Group 1 will be fed by applying ''elastic sac'' at the first feeding hour after they are
      included in the study and in the next feeding they will be fed without performing any
      application. Infants in Group 2 will be fed without performing any application at the first
      feeding hour after they are included in the study and they will be fed at the second feeding
      hour by applying ''elastic sac''. Infants in both groups will be fed by the researcher with a
      bottle in a semi-fowler right lateral position during feeding hours. During feeding, the
      effect of the elastic sac on the infant's feeding status and physiological parameters will be
      evaluated.
    

Detailed description: 
      Swaddling method is a method which can be used for preserving thermoregulation, decreasing
      stress and maintaining comfort in term and preterm infants during painful procedures. The
      effect of the ''elastic sac'' method which is thought to imitate the uterus environment, on
      physiological parameters and feeding performance of infants during feeding will be evaluated.
      The ''elastic sac'' method will be applied with 100% cotton and elastic fabric. The
      single-use elastic and cotton fabric was sewed as a U-shaped sac for each infant included in
      the study. The infant will be placed in the sac during the feeding hour and will be placed in
      a position in which he/she can move easily, maintain the flexion posture and feel safe
      contrary to traditional swaddling. The purpose of the study is to evaluate stress-associated
      physiological parameters and feeding status during oral feeding in preterm infants starting
      oral feeding. The study will be conducted using the crossover randomized controlled method.
      The sample size of the study was determined via the power analysis in accordance with the
      results obtained from studies conducted via a similar research method. According to the
      results of the analyses, a total of 26 preterm infants including 13 for each group will be
      included in the study group. After informing the families of infants meeting the inclusion
      criteria both in written and oral forms, the study will be conducted with mothers who agree
      to participate in the study and their infants.

      Application Stages GROUP 1

        1. Feeding Time Half an hour before the feeding time, the infant's heart rate and oxygen
           saturation will be recorded in the observation form. The infant will be placed in the
           ''elastic sac'' and the angle of the incubator bed will be elevated 45 degrees. He/she
           will be laid in the right lateral position within the nest and will be allowed to take a
           rest within the ''elastic sac'' until the feeding time (30 minutes). Giving priority to
           breast milk, formula milk at optimum temperature will be prepared for infants without
           breast milk. The nutrient amount ordered by the doctor will be put in the bottle. Ten
           minutes before the feeding time, the infant's heart rate and oxygen saturation will be
           recorded in the observation form every two minutes. At the feeding time, the bottle will
           be approached to the infant's mouth for feeding in the semi-fowler right lateral
           position at 45 degrees without making any change in his/her posture. As soon as the
           infant begins to suck, the chronometer will be started and the infant's heart rate and
           oxygen saturation will be recorded by another observer nurse every two minutes
           throughout feeding. When the infant shows signs of fatigue (Spo2 less than 90, HR higher
           than 160), the feeding will be discontinued and when the infant's HR fall below 160 and
           spO2 increases above 90, the feeding will continue. The time of feeding will be limited
           to a maximum of 30 minutes. When the infant stops feeding, the chronometer will be
           stopped, the feeding will be terminated and the infant will be allowed to take a rest.
           His/her heart rate and oxygen saturation will be recorded in the observation form every
           two minutes for ten minutes. Then, the ''elastic sac'' application will be terminated
           and an onesie will be put on the infant in line with the care procedures of the clinic
           and he/she will be allowed to take a rest until the next feeding hour. The amount (cc)
           of milk the infant receives from the ordered amount of the milk and the amount of
           nutrient he/she receives in a minute will be calculated and recorded in the observation
           form.

        2. Feeding Time Half an hour before the feeding time, the infant's heart rate and oxygen
           saturation will be recorded in the observation form. The angle of the incubator bed will
           be elevated 45 degrees. Only an onesie will be put on the infant in line with the care
           procedures of the clinic and no other application will be performed. He/she will be laid
           in the right lateral position within the nest and will be allowed to take a rest until
           the feeding time. In order to feed him/her the same nutrient at both feeding hours, the
           same nutrient prepared at the previous feeding hour will be prepared at optimum
           temperature. The nutrient amount ordered by the doctor will be put in the bottle. Ten
           minutes before the feeding hour, the infant's heart rate and oxygen saturation will be
           recorded in the observation form every two minutes. At the feeding hour, the bottle will
           be approached to the infant's mouth for feeding in the semi-fowler right lateral
           position at 45 degrees without making any change in his/her position. As soon as the
           infant begins to suck, the chronometer will be started and the infant's heart rate and
           oxygen saturation will be recorded by another observer nurse every two minutes
           throughout feeding. When the infant shows signs of fatigue (Spo2 less than 90, HR higher
           than 160), the feeding will be discontinued and when the infant's HR falls below 160 and
           spO2 increases above 90, the feeding will continue. The time of feeding will be limited
           to a maximum of 30 minutes. When the infant stops feeding, the chronometer will be
           stopped, the feeding will be terminated and the infant will be allowed to take a rest.
           His/her heart rate and oxygen saturation will be recorded in the observation form every
           two minutes for ten minutes. The infant will be allowed to take a rest in line with the
           care procedures of the clinic. The amount (cc) of milk the infant receives from the
           ordered amount of the milk and the amount of nutrient he/she receives in a minute will
           be calculated and recorded in the observation form.

      GROUP 2

        1. Feeding Time Half an hour before the feeding time, the infant's heart rate and oxygen
           saturation will be recorded in the observation form. The angle of the incubator bed will
           be elevated 45 degrees. Only an onesie will be put on the infant in line with the care
           procedures of the clinic and no other application will be performed. He/she will be laid
           in the right lateral position within the nest and will be allowed to take a rest until
           the feeding time (30 minutes). Giving priority to breast milk, formula milk at optimum
           temperature will be prepared for infants without breast milk. The nutrient amount
           ordered by the doctor will be put in the bottle. Ten minutes before the feeding hour,
           the infant's heart rate and oxygen saturation will be recorded in the observation form
           every two minutes. At the feeding hour, the bottle will be approached to the infant's
           mouth for feeding in the semi-fowler right lateral position at 45 degrees without making
           any change in his/her position. As soon as the infant begins to suck, the chronometer
           will be started and the infant's heart rate and oxygen saturation will be recorded by
           another observer nurse every two minutes throughout feeding. When the infant shows signs
           of fatigue (Spo2 less than 90, HR higher than 160), the feeding will be discontinued and
           when the infant's HR falls below 160 and spO2 increases above 90, the feeding will
           continue. The time of feeding will be limited to a maximum of 30 minutes. When the
           infant stops feeding, the chronometer will be stopped, the feeding will be terminated
           and the infant will be allowed to take a rest. His/her heart rate and oxygen saturation
           will be recorded in the observation form every two minutes for ten minutes. The infant
           will be allowed to take a rest until the next feeding hour in line with the care
           procedures of the clinic. Amount (cc) of milk the infant receives from the ordered
           amount of the milk and the amount of nutrient he/she receives in a minute will be
           calculated and recorded in the record form.

        2. Feeding Time Half an hour before the feeding time, the infant's heart rate and oxygen
           saturation will be recorded in the observation form. The infant will be placed in the
           ''elastic sac'' and the angle of the incubator bed will be elevated 45 degrees. He/she
           will be laid in the right lateral position within the nest and will be allowed to take a
           rest within the elastic sac until the feeding time. In order to feed him/her the same
           nutrient at both feeding hours, the same nutrient prepared during the previous feeding
           hour will be prepared at optimum temperature. The nutrient amount ordered by the doctor
           will be put in the bottle. Ten minutes before the feeding time, the infant's heart rate
           and oxygen saturation will be recorded in the observation form every two minutes. At the
           feeding time, the bottle will be approached to the infant's mouth for feeding in the
           semi-fowler right lateral position at 45 degrees without making any change in his/her
           position. As soon as the infant begins to suck, the chronometer will be started and the
           infant's heart rate and oxygen saturation will be recorded by another observer nurse
           every two minutes throughout feeding. When the infant shows signs of fatigue (Spo2 less
           than 90, HR higher than 160), the feeding will be discontinued and when the infant's HR
           falls below 160 and spO2 increases above 90, the feeding will continue. The time of
           feeding will be limited to a maximum of 30 minutes. When the infant stops feeding, the
           chronometer will be stopped, the feeding will be terminated and the infant will be
           allowed to take a rest. His/her heart rate and oxygen saturation will be recorded in the
           observation form every two minutes for ten minutes. Then, the ''elastic sac''
           application will be terminated and he/she will be allowed to take a rest in line with
           the care procedures of the clinic. The amount (cc) of milk the infant receives from the
           ordered amount of the milk and the amount of nutrient he/she receives in a minute will
           be calculated and recorded in the observation form.
    

Intervention name(s): Elastic Sac; Control
Intervention type(s): Other; Other
Intervention description(s): Half an hour before the feeding time, the infant will be placed in the elastic sac, be laid in the right lateral position within the nest with an angle of 45 degrees and will be allowed to take a rest within the elastic sac for half an hour. At the feeding time, he/she will be fed by the researcher with a bottle in the right lateral position within the elastic sac with an angle of 45 degrees without making any change in his/her position.; Half an hour before the feeding time, the infant will be laid in the right lateral position within the nest with an angle of 45 degrees without performing any different application and will be allowed to take a rest. At the feeding time, he/she will be fed by the researcher with a bottle in the right lateral position within the elastic sac with an angle of 45 degrees without making any change in his/her position.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Heart rate; Oxygen Saturation; Preterm Infants; Safe Swaddling