The Effect of Elastic Sac on Feeding

NCT05154357 | Completed DMC

• 1 other identifier: E-74555795-050.01.04-88001
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Oxygen Saturation; Heart Rate; Nutritional Status

Keywords

Heart rate; Oxygen Saturation; Preterm Infants; Safe Swaddling

Outcome Measures

Primary Outcomes (1)

• Feeding Status

  In order to assess the feeding status of the infant, his/her time of feeding and the amount of nutrient he/she receives in a minute will be calculated. In order to determine his/her time of feeding, a phone chronometer will be started as soon as he/she begins feeding and it will be stopped when feeding is over. All infants in Group 1 and Group 2 will be fed with a slow-flow bottle branded Avent which is designed for premature infants. It will be calculated how much (cc) of the total amount of nutrient ordered by the doctor the infant receives. The total amount of nutrient received by the infant will be divided into the time of feeding and thus the amount of nutrient received in a minute (cc) will be calculated.

  maximum 30 minutes

Secondary Outcomes (2)

• Heart Rate

  All babies in Group 1 and Group 2 will be recorded in the registration form by the observing nurse once half an hour before the feeding time, 10 minutes before the feeding time, during the feeding and at 2-minute intervals 10 minutes after the feeding.

• Oxygen Saturation

  All babies in Group 1 and Group 2 will be recorded in the registration form by the observing nurse once half an hour before the feeding time, 10 minutes before the feeding time, during the feeding and at 2 minutes intervals 10 minutes after the feeding.

Study Arms (2)

Group 1

EXPERIMENTAL

Half an hour before the first feeding hour, the infant's heart rate and oxygen saturation will be recorded. Then, he/she will be placed in the elastic sac, positioned and will be allowed to take a rest until the feeding hour for 30 minutes. His/her physiological parameters will be recorded ten minutes before the feeding time, during feeding and ten minutes after feeding. When the feeding time begins, the chronometer will be started and it will be stopped when feeding is completed. At the second feeding time, the infant's heart rate and oxygen saturation will be recorded half an hour before the feeding hour. Then, he/she will be positioned without performing any different application and will be allowed to take a rest until the feeding time. His/her physiological parameters will be recorded ten minutes before the feeding time, during feeding and ten minutes after feeding. When feeding begins, the chronometer will be started and when it is over, the chronometer will be stopped.

Other: Elastic Sac; Other: Control

Group 2

EXPERIMENTAL

Half an hour before the first feeding time of the infant, his/her heart rate and oxygen saturation will be recorded. Then, he/she will be positioned without performing any different application and will be allowed to take a rest until the feeding time. His/her physiological parameters will be recorded ten minutes before the feeding hour, during feeding and ten minutes after feeding. When feeding begins, the chronometer will be started and when it is over, the chronometer will be stopped. At the second feeding hour, the infant's heart rate and oxygen saturation will be recorded half an hour before the feeding hour. Then, he/she will be placed in the elastic sac, positioned, and allowed to take a rest until the feeding hour. His/her physiological parameters will be recorded ten minutes before the feeding hour, during feeding and ten minutes after feeding. When feeding begins, the chronometer will be started and when it is over, the chronometer will be stopped.

Other: Elastic Sac; Other: Control

Interventions

Elastic Sac OTHER

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.

Group 1; Group 2

Control OTHER

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.

Group 1; Group 2

Eligibility Criteria

• Age: 32 Weeks - 40 Weeks
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Parent agreeing to take part in the study
• Infant starting oral feeding by the doctor in the neonatal intensive care unit and tolerating it
• Infant born at 26-36+6 gestational week specified according to the last menstruation date of the mother
• Infant being at 32-39+6 postmenstrual week
• Infant having a body weight of 1500 grams and above
• Infant being fed orally once before and tolerating it
• Infant having no health problem except for being a preterm

You may not qualify if:

• Infant having a gastrointestinal, neurological or genetic illness (such as necrotizing enterocolitis, intracranial bleeding, hydrocephaly, omophalocele, down's syndrome, gastroschisis) and other illnesses
• Infant having no obstacle to oral feeding (such as cleft palate, cleft lip, facial muscle paralysis, craniofacial anomaly)
• Infant being on oxygen support

Sponsors & Collaborators

• Istanbul University - Cerrahpasa: lead

Study Sites (1)

Istanbul University, Cerrahpaşa

Istanbul, Turkey (Türkiye)

Location

Study Officials

• Duygu GÖZEN, Prof.

  Istanbul University - Cerrahpasa

  PRINCIPAL INVESTIGATOR

• Fatma Narter Kaya, Assoc. Prof.

  Istanbul Dr. Lütfi Kırdar Şehir Hastanesi

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant

Study Record Dates

• First Submitted: November 5, 2021
• First Posted: December 13, 2021
• Study Start: August 3, 2021
• Primary Completion: May 3, 2022
• Study Completion: July 5, 2022
• Last Updated: July 27, 2022

Record last verified: 2022-07

Locations

TU (1)