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The Effect of Position Given to Preterms After Feeding on Gastric Residual Volume, Abdominal Oxygenation and Fractional Oxygen Extraction

Primary Purpose

Determination of the Effect of Position Given to Preterms After Feeding on Gastric Residual Volume, Abdominal Oxygenation and Fractional Oxygen Extraction

Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Positioning (Prone, right lateral and semi-raised supine position)
Sponsored by
Istanbul University - Cerrahpasa (IUC)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Determination of the Effect of Position Given to Preterms After Feeding on Gastric Residual Volume, Abdominal Oxygenation and Fractional Oxygen Extraction

Eligibility Criteria

28 Weeks - 33 Weeks (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Preterm newborns who are at 28-33 weeks of gestation according to the last menstrual period of the mother, breastfed, clinically stable and enteral feeding started, first enteral nutrition after mechanical ventilation, at least 50% of their nutrition provided with enteral nutrition, free Newborns fed by flow and orogastric tube and with informed consent of the parents will be included in the study. Exclusion Criteria: Newborns requiring mechanical ventilation, diagnosed with NEC, vomiting, abdominal distension, nasal mechanical obstruction, congenital anomalies, gastrointestinal problems such as gastroschisis or congenital diaphragmatic hernia, cerebrovascular disease, apnea episodes, severe neurological disease, were included in the study. will not be included. Preterm newborns who worsen clinically after inclusion in the sample group will be excluded from the study.

Sites / Locations

  • Hande ÖzgörüRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Intervention group 1

Intervention group 2

Intervention group 3

Arm Description

Preterm newborns will be placed in the supine position during feeding. Feeding will be done every 2-3 hours. Preterm newborns will be positioned in one position for 2 hours after feeding. Group 1 will be given the prone, right lateral and semi-raised supine positions, respectively, during three feedings, each position after one feeding.

Preterm newborns will be placed in the supine position during feeding. Feeding will be done every 2-3 hours. Preterm newborns will be positioned in one position for 2 hours after feeding. Group 2 will be given semi-raised supine, prone and right lateral positions, respectively, during three feedings, each position being one post feeding.

Preterm newborns will be placed in the supine position during feeding. Feeding will be done every 2-3 hours. Preterm newborns will be positioned in one position for 2 hours after feeding. Group 3 will be given the right lateral, semi-raised supine and prone positions, respectively, during three feedings, each position being one post feeding.

Outcomes

Primary Outcome Measures

Does position affect gastric residual volume in preterm neonates?
Gastric residual volume: Gastric residual volume will be controlled manually using a 5 ml syringe prior to feeding. Gastric residue will be excreted or given back in consultation with the doctor according to its amount and color. Breast Milk: Name and date control of milk stored in milk storage bags in the refrigerator will be made. The breast milk drawn into the injector in accordance with the hygiene rules will be given to the preterm newborn after it reaches the appropriate temperature (must be at body temperature) in hot water. Heating breast milk above 40°C is not recommended as it will destroy immunologically active factors.In all three intervention groups, gastric residue will be checked with a 5 ml injector just before feeding, and the residual content will be discarded or returned with the decision of the doctor.
Does position have an effect on abdominal oxygenation and physiological parameters in preterm newborns?
Preterm neonates who meet the inclusion criteria will be monitored through the NIRS for three feedings. Average NIRS values will be calculated for periods immediately before, during and after feeding. NIRS values will be recorded by the monitor, after the monitoring, the picture of the records will be taken from the monitor. During the follow-up, the location of the probe and the NIRS value will be followed by the nurse who collects data. The probe position will be changed to be in the lower abdomen before each feeding during the follow-up period. While NIRS values are recorded, pulse oximetry values will also be recorded. An increase in fractional oxygen extraction indicates increased oxygen extraction by tissue, while a decrease in FOE indicates less oxygen use or increased oxygen delivery. Its normal value is between 15-33%. In our study, pulse oximetry and NIRS monitor will be used together to evaluate physiological parameters and determine fractional oxygen extraction.

Secondary Outcome Measures

Full Information

First Posted
May 24, 2023
Last Updated
May 24, 2023
Sponsor
Istanbul University - Cerrahpasa (IUC)
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1. Study Identification

Unique Protocol Identification Number
NCT05888090
Brief Title
The Effect of Position Given to Preterms After Feeding on Gastric Residual Volume, Abdominal Oxygenation and Fractional Oxygen Extraction
Official Title
The Effect of Position Given to Preterms After Feeding on Gastric Residual Volume, Abdominal Oxygenation and Fractional Oxygen Extraction
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 1, 2023 (Anticipated)
Primary Completion Date
July 1, 2024 (Anticipated)
Study Completion Date
July 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istanbul University - Cerrahpasa (IUC)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes

5. Study Description

Brief Summary
It was aimed to investigate the effects of three different positions after feeding on gastric residual volume, abdominal oxygenation using near infrared spectroscopy (NIRS), and fractional oxygen extraction values in preterm breastfed newborns.
Detailed Description
Type and Design of Research This study was planned in a randomized crossover study design to evaluate the effects of three different positions on gastric residual volume, fractional oxygen extraction and abdominal oxygenation in clinically stable breastfed preterm newborns. The order of the 3 positions that will be given to the babies in the research group will be determined by drawing lots and 3 intervention groups will be formed. Preterm newborns in each intervention group will be followed for two hours after feeding in all three positions: semi-elevated supine position, prone position, and right lateral position. Positions will be given to babies, taking into account the order of positions in each group. All positions will be applied once to each baby. Groups and position rankings according to the result of the draw: st group: Prone, right lateral and semi-raised supine position nd group: Semi-raised supine, prone and right lateral position rd group: Right lateral, semi-raised supine and prone position 48 preterm newborns in the study group will be randomly assigned to these 3 intervention groups. In order to determine which baby will be in which group, the numbers from 1 to 48 were distributed to 3 groups through a program in the computer environment without repeating the number (https://www.randomizer.org/). Randomization is provided as follows. Intervention group 1: 2.8,12,17,18,22,24,25,26,31,33,36,37,40,42,45 Intervention group 2: 1,3,5,10,14,16,19,20,27,28,29,30,32,34,43,44 Intervention group 3: 4,6,7,9,11,13,15,21,23,35,38,39,41,46,47,48 Location and Time of Research Data of the research Istanbul Kartal Dr. Lütfi Kırdar City Hospital will meet at the Newborn Intensive Care Unit between July 2023 and July 2024. 2.,3. and the university hospital, which provides 4A level intensive care, consists of a total of 41 beds. It consists of 14 level beds, 3rd level 14 beds and 13 beds with 4A level. Survey's Universe and Sampling After the necessary legal permits have been obtained in the universe of the research, (Ethical Board approval and institution permit ), Kartal Dr. at the time of the investigation. The preterm followed by the Lütfi Kırdar City Hospital Newborn Intensive Care Unit will create newborns. The sample of the research is Eagle Dr. Lütfi Kırdar City Hospital will create 48 preterm newborns with 28-33 gestation weeks, which are hospitalized between March 2023 and March 2024, which meet the inclusion criteria and received written consent from their parents. Intake swallowing coordination but 32-34. Since it develops after the gestation week, (Törüner ve Büyükgönenç, 2012) sampling will be included in preterm newborns smaller than the 34th gestation week. Power analysis was performed using the G*Power (v3.1.9.2) program to determine the number of samples. The strength of the study is 1-β (β = II. The probability of type error is expressed as ) and in general research should have 80% power. S. S. Based on the study of Ceylan et al, the effect size of the calculation result made based on the difference of Gastric residuals (ml) measurements according to the supine and right lateral position was calculated as d=0.420 and at the level of α=0.05 %It has been calculated that there must be at least 47 babies in total to get 80 powers. Considering the loss of case, the number of samples was determined as 48. Inclusion criteria; Preterm newborns who are in the 28-33 gestation week according to the mother's last men's history, are the 1st enteral feeding after mechanical ventilation, fed with breast milk, clinically stable and enteral nutrition, Newborns provided with at least 50% ' of enteral nutrition, fed with free flow and orogastric probe, and received informed consent from parents will be included in the study. Exclusion criteria; With cerebrovascular disease, with a need for mechanical ventilation, diagnosed with NEC, vomiting, abdominal distension, nasal mechanical obstruction, congenital anomaly, gastrochysis or congenital diaphragm hernia, Newborns with apnea episodes, severe neurological disease will not be included in the study. Preterm newborns that worsen clinically after being included in the sample group will be removed from the study. Independent variables: Positioning (Prone, right lateral and semi-raised supine position) Dependent variables: Preterm newborn abdominal NIRS value, fractional oxygen extraction value, gastric residual volume. Research Hypotheses H0: There is no difference between the effects of the three positions on gastric residual volume, abdominal oxygenation, and fractional oxygen extraction. H1: Abdominal oxygenation and oxygen level (SPO2) are higher in the prone position than in the semi-raised supine position and the right lateral position. H2: Abdominal oxygenation and oxygen level (SPO2) are higher in the right lateral position than in the semi-raised supine position. H3: The amount of gastric residual volume in the prone position is lower than in the semi-raised supine position and the right lateral position. H4: The amount of gastric residual volume in the right lateral position is lower than in the semi-raised supine position. H5: Fractional oxygen extraction in the prone position is lower than in the right lateral and semi-elevated supine position. Data Collection Method The data were collected from Kartal Dr. It will be collected in the neonatal intensive care unit of Lütfi Kırdar City Hospital. Study data will be collected by two scholarship nurses working in that unit, Nurse Merve Yaylacı and Nurse Elif Kaya İnegöl. The researcher responsible for the study, the subjects, and the statistician who will analyze the study will be blinded to the data. In the study, the blinding technique was planned as three blinds. Introductory information and data collection form The intervention group of each preterm newborn included in the sample, week of gestation (according to last menstrual period), date, type of delivery, postnatal age, birth weight, postnatal body weight, gender, receiving intravenous fluid support, mean NIRS value, heart rate, and saturation value, amount and color of gastric residual volume before feeding, presence of a disease requiring medical treatment will be recorded. To assess abdominal oxygenation (ArSO2), the NIRS sensor probe will be placed over the lower abdomen (under the umbilicus) and monitored. Preterm neonates who meet the inclusion criteria will be monitored through the NIRS for three feedings. Average NIRS values will be calculated for periods immediately before, during and after feeding. NIRS values will be recorded by the monitor, after the monitoring, the picture of the records will be taken from the monitor. During the follow-up, the location of the probe and the NIRS value will be followed by the nurse who collects data. The probe position will be changed to be in the lower abdomen before each feeding during the follow-up period. While NIRS values are recorded, pulse oximetry values will also be recorded. Materials to be used Gastric residual volume Gastric residual volume will be checked manually using a 5 ml syringe prior to feeding. Gastric residue will be excreted or given back in consultation with the doctor according to its amount and color. Breast Milk: Name and date control of the milk stored in milk storage bags in the refrigerator will be made. The breast milk drawn into the injector in accordance with the hygiene rules will be given to the preterm newborn after it reaches the appropriate temperature (must be at body temperature) in hot water. Heating breast milk above 40°C is not recommended as it will destroy immunologically active factors. Positioning: Preterm newborns will be placed in the supine position during feeding. Feeding will be done every 2-3 hours. Preterm newborns will be positioned in one position for 2 hours after feeding. Semi-raised supine position prone position Right lateral position Data Collection Feeding time will take 10-20 minutes. Preterm neonates will be included in the sampling from their 1st feeding after weaning off the mechanical ventilator. The procedure will begin when babies in all groups are calm. The entire application process will be carried out in the neonatal intensive care unit and all materials will be prepared before the procedure. In all three intervention groups, gastric residue will be checked with a 5 ml injector just before feeding, and the residual content will be discarded or returned with the decision of the doctor. The NIRS sensor probe will be attached to the lower abdomen. Since the cost of the probes is high, reversebl probes will be used and their cleaning will be provided with high-level disinfectant (Ecolab wipes). One NIRS probe will be used for two preterm neonates. The same enteral feeding protocol will be applied to all preterm newborns. In the institution where the study will be conducted, minimal enteral nutrition is started in preterm newborns, with breast milk being the first choice after 24 hours postnatally. Then, if the preterm newborn can tolerate enteral feeding, the amount is gradually increased each day. Decisions to increase feeding volume, stop feeding and use breast milk fortifier are made by the clinical team based on local protocols. The amount and frequency of feeding will be decided according to the gestational week, body weight and clinical condition of the preterm newborn. Data analysis NCSS (Number Cruncher Statistical System) 2020 Statistical Software (NCSS LLC, Kaysville, Utah, USA) program will be used for statistical analysis. While evaluating the study data, Shapiro Wilks test and Box Plot charts will be used to evaluate the conformity of the data to the normal distribution, as well as descriptive statistical methods (mean, standard deviation, median, frequency and ratio). Student's t test in the evaluation of two groups of normally distributed variables; Oneway Anova test will be used in the comparison of three groups and above, and the Bonferroni test will be used to determine the group that causes the difference. Repeated Measures test for evaluations according to three positions within the group; Bonferroni test will be used in post hoc evaluations and Paired Sample t test will be used in peer-to-peer evaluations. Mann Whitney U test in the evaluation of non-normally distributed variables according to two groups; Kruskal Wallis test will be used in the comparison of three groups and above, and Dunn test will be used to determine the group causing the difference. Friedman test post hoc Dunn test in the evaluations according to three positions within the group; Wilcoxon Signed Rank test will be used for peer-to-peer evaluations. Pearson or Spearman's correlation analysis will be used according to the distribution in the evaluation of the relations between the variables; Linear regression models will be made in further evaluations. Chi-square test and Fisher's Exact test will be used in the comparison of qualitative data. The results will be evaluated at the 95% confidence interval, at the p<0.05 level of significance.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Determination of the Effect of Position Given to Preterms After Feeding on Gastric Residual Volume, Abdominal Oxygenation and Fractional Oxygen Extraction

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Breastfed preterm neonates to be included in the study will be placed in 3 positions in a randomized crossover design. The order of the 3 positions that will be given to the babies in the research group will be determined by drawing lots and 3 intervention groups will be formed. Preterm newborns in each intervention group will be followed for two hours after feeding in all three positions: semi-elevated supine position, prone position, and right lateral position. Positions will be given to babies, taking into account the order of positions in each group. All positions will be applied once to each baby. Groups and position rankings according to the result of the draw: st group: Prone, right lateral and semi-raised supine position nd group: Semi-raised supine, prone and right lateral position rd group: Right lateral, semi-raised supine and prone position 48 preterm newborns in the study group will be randomly assigned to these 3 intervention groups.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
48 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention group 1
Arm Type
Experimental
Arm Description
Preterm newborns will be placed in the supine position during feeding. Feeding will be done every 2-3 hours. Preterm newborns will be positioned in one position for 2 hours after feeding. Group 1 will be given the prone, right lateral and semi-raised supine positions, respectively, during three feedings, each position after one feeding.
Arm Title
Intervention group 2
Arm Type
Experimental
Arm Description
Preterm newborns will be placed in the supine position during feeding. Feeding will be done every 2-3 hours. Preterm newborns will be positioned in one position for 2 hours after feeding. Group 2 will be given semi-raised supine, prone and right lateral positions, respectively, during three feedings, each position being one post feeding.
Arm Title
Intervention group 3
Arm Type
Experimental
Arm Description
Preterm newborns will be placed in the supine position during feeding. Feeding will be done every 2-3 hours. Preterm newborns will be positioned in one position for 2 hours after feeding. Group 3 will be given the right lateral, semi-raised supine and prone positions, respectively, during three feedings, each position being one post feeding.
Intervention Type
Other
Intervention Name(s)
Positioning (Prone, right lateral and semi-raised supine position)
Intervention Description
One of the developmental care practices applied to preterm newborns is positioning. It is one of the important nursing interventions for nurses to position newborns in the most appropriate position according to their condition (Sajadi et al., 2019). There are studies expressing that positioning affects gastric residual volume and feeding tolerance in preterm newborns. However, the results differ from one study to another (Yayan et al., 2018). No study has been found to evaluate the effects of body position on abdominal oxygenation in preterm neonates.
Primary Outcome Measure Information:
Title
Does position affect gastric residual volume in preterm neonates?
Description
Gastric residual volume: Gastric residual volume will be controlled manually using a 5 ml syringe prior to feeding. Gastric residue will be excreted or given back in consultation with the doctor according to its amount and color. Breast Milk: Name and date control of milk stored in milk storage bags in the refrigerator will be made. The breast milk drawn into the injector in accordance with the hygiene rules will be given to the preterm newborn after it reaches the appropriate temperature (must be at body temperature) in hot water. Heating breast milk above 40°C is not recommended as it will destroy immunologically active factors.In all three intervention groups, gastric residue will be checked with a 5 ml injector just before feeding, and the residual content will be discarded or returned with the decision of the doctor.
Time Frame
10 months
Title
Does position have an effect on abdominal oxygenation and physiological parameters in preterm newborns?
Description
Preterm neonates who meet the inclusion criteria will be monitored through the NIRS for three feedings. Average NIRS values will be calculated for periods immediately before, during and after feeding. NIRS values will be recorded by the monitor, after the monitoring, the picture of the records will be taken from the monitor. During the follow-up, the location of the probe and the NIRS value will be followed by the nurse who collects data. The probe position will be changed to be in the lower abdomen before each feeding during the follow-up period. While NIRS values are recorded, pulse oximetry values will also be recorded. An increase in fractional oxygen extraction indicates increased oxygen extraction by tissue, while a decrease in FOE indicates less oxygen use or increased oxygen delivery. Its normal value is between 15-33%. In our study, pulse oximetry and NIRS monitor will be used together to evaluate physiological parameters and determine fractional oxygen extraction.
Time Frame
10 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
28 Weeks
Maximum Age & Unit of Time
33 Weeks
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Preterm newborns who are at 28-33 weeks of gestation according to the last menstrual period of the mother, breastfed, clinically stable and enteral feeding started, first enteral nutrition after mechanical ventilation, at least 50% of their nutrition provided with enteral nutrition, free Newborns fed by flow and orogastric tube and with informed consent of the parents will be included in the study. Exclusion Criteria: Newborns requiring mechanical ventilation, diagnosed with NEC, vomiting, abdominal distension, nasal mechanical obstruction, congenital anomalies, gastrointestinal problems such as gastroschisis or congenital diaphragmatic hernia, cerebrovascular disease, apnea episodes, severe neurological disease, were included in the study. will not be included. Preterm newborns who worsen clinically after inclusion in the sample group will be excluded from the study.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
HANDE ÖZGÖRÜ
Phone
05379381855
Email
hande.ozgoru@ogr.iuc.edu.tr
Facility Information:
Facility Name
Hande Özgörü
City
Merkez
State/Province
Isparta
ZIP/Postal Code
32000
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
HANDE ÖZGÖRÜ
Phone
05379381855

12. IPD Sharing Statement

Plan to Share IPD
No
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The Effect of Position Given to Preterms After Feeding on Gastric Residual Volume, Abdominal Oxygenation and Fractional Oxygen Extraction

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