The Effect of Feeding Positions During Tube Feeding on Stress, Pain Level and Feeding Tolerance of Preterm Infants

Sponsor
Sibel Serap Ceylan (Other)
Overall Status
Completed
CT.gov ID
NCT04156529
Collaborator
(none)
34
1
2
3.7
9.1

Study Details

Study Description

Brief Summary

Premature infants have a need for an orogastric or nasogastric feeding tube because of the immaturity of coordination between suck-swallow and breathing. Tube feeding could cause feeding intolerance and stress. One of the recommendations to prevent feeding intolerance is giving suitable position during tube feeding. Also, feeding intolerance is related to stress. The aim of this study was to investigate the effect of semi-elevated supine (ESU) and semi-elevated right lateral (ESRL) positions on the stress, pain levels and feeding tolerance of premature infants during the tube feeding (TF). This was a clinical trial with a crossover design in which subjects randomly received a sequence of either ESU position or ESRL position, during the TF.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: ESU position
  • Behavioral: ESRL position
N/A

Detailed Description

Purpose: The aim of this study was to investigate the effect of semi-elevated supine (ESU) and semi-elevated right lateral (ESRL) positions on the stress, pain levels and feeding tolerance of premature infants during the tube feeding (TF).

Method: This was a clinical trial with a crossover design in which subjects randomly received a sequence of either ESU position or ESRL position, during the TF. The sample size calculation was based on the crossover design. It assumed criteria that included the expectation of minimal differences in the average pain and stress score, 1.0; a difference of 2.0 in the standard deviation between ESU and ESRL positions; power, 0.80 and p < .05. The sample size was calculated to be 34 participants. The inclusion criteria for participants were 30-34 weeks gestational age, stable vital signs, no oral feeding skills, feeding by orogastric tube, and had parental consent. Exclusion criteria were respiratory distress, congenital anomalies, necrotizing enterocolitis history, neurological and cardiological problems, receiving analgesic, sedative, or muscle relaxant medication that may affect pain and stress. The position to be given to the participants during TF first was determined by randomization. The sequence of feeding position was randomized by computer. Sixteen of the infants started TF with ESU position, whereas the other 18 started with ESRL position.

The study data were collected with "Descriptive Properties Form of Premature Newborn", Premature Newborn Follow-up Form", "Newborn Stress Scale", "ALPS-Neo Newborn Pain and Stress Assessment Scale".

For each participant, two feeding positions were applied at consecutive feeding time. Feeding tolerance was assessed by abdominal circumference measurements and checking gastric residuals. The abdominal circumference of the participants was measured with a tape measure before and after TF. Vital signs and oxygen saturation levels were measured before, during and after TF. The stress and pain levels of the participants were evaluated independently by the researchers before, during and after TF. Significance level p <0.05 was used for all statistical analyses. Ethics committee approval, written permission from institutions and families were obtained for conducting the study.

Study Design

Study Type:
Interventional
Actual Enrollment :
34 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Single (Participant)
Primary Purpose:
Supportive Care
Official Title:
The Effect of Two Different Feeding Positions During Tube Feeding on Stress, Pain Level and Feeding Tolerance of Preterm Infants
Actual Study Start Date :
May 6, 2019
Actual Primary Completion Date :
Aug 15, 2019
Actual Study Completion Date :
Aug 28, 2019

Arms and Interventions

Arm Intervention/Treatment
Experimental: ESU position

Firstly, the semi-elevated supine position was given to participants during tube feeding

Behavioral: ESU position
Semi-elevated supine (ESU) position was given during tube feeding

Behavioral: ESRL position
Semi-elevated right lateral (ESRL) position was given during tube feeding

Experimental: ESRL position

Firstly, the semi-elevated right lateral position was given to participants during tube feeding

Behavioral: ESU position
Semi-elevated supine (ESU) position was given during tube feeding

Behavioral: ESRL position
Semi-elevated right lateral (ESRL) position was given during tube feeding

Outcome Measures

Primary Outcome Measures

  1. Neonatal pain [Four month]

    ALPS-Neo Newborn Pain and Stress Assessment Scale was used. The ALPS-Neo is a five-item scale including facial expression, breathing pattern, tone of extremities, hand and foot activity, and level of activity. The lowest and the highest scores obtainable from the scale are 0 and 10, respectively. As the score increases, stress and pain increase.

  2. Neonatal stress [Four month]

    Newborn Stress Scale was used. The scale includes eight items: face expression, color, respiration, activity level, consolation, muscle tone, extremities, and posture. Each item is scored on the scale 0-2. The minimum score is 0 and the maximum score is 16. As the score increases, the stress level of the infant increases.

  3. Feeding intolerance [Four month]

    Abdominal circumference measurements and checking gastric residuals. The abdominal circumference of the participants was measured with a tape measure before and after TF.

Secondary Outcome Measures

  1. Heart Rate [Four month]

    A pulse oximetry probe was attached to the foot to measure heart rate. The number of heartbeats per minute was observed from the pulse oximetry monitor.

  2. Oxygen Saturation [Four month]

    Oxygen saturation (SpO2) was obtained using a pulse oximetry device. Pulse oximetry measures peripheral arterial oxygen saturation (%) as a surrogate marker for tissue oxygenation.

  3. Respiratory Rate [Four month]

    The respiratory rate is the number of breaths a person takes per minute. Respiratory rate was measured by observation.

Eligibility Criteria

Criteria

Ages Eligible for Study:
30 Weeks to 34 Weeks
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • 30-34 weeks gestational age,

  • stable vital signs,

  • no oral feeding skills,

  • feeding by orogastric tube,

  • had parental consent

Exclusion Criteria:
  • respiratory distress,

  • congenital anomalies,

  • necrotizing enterocolitis history,

  • neurological and cardiological problems,

  • receiving analgesic, sedative, or muscle relaxant medication that may affect pain and stress

Contacts and Locations

Locations

Site City State Country Postal Code
1 Sibel Serap Ceylan Denizli Turkey 20100

Sponsors and Collaborators

  • Sibel Serap Ceylan

Investigators

  • Study Director: Sibel Serap Ceylan, Pamukkale Univesity

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Sibel Serap Ceylan, Principal Investigator, Pamukkale University
ClinicalTrials.gov Identifier:
NCT04156529
Other Study ID Numbers:
  • PamukkaleUniversity
First Posted:
Nov 7, 2019
Last Update Posted:
Nov 8, 2019
Last Verified:
Nov 1, 2019
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Sibel Serap Ceylan, Principal Investigator, Pamukkale University

Study Results

No Results Posted as of Nov 8, 2019