Clinical trial NCT04156529: The Effect of Feeding Positions During Tube Feeding on Stress, Pain Level and Feeding Tolerance of Preterm Infants
Official title: The Effect of Two Different Feeding Positions During Tube Feeding on Stress, Pain Level and Feeding Tolerance of Preterm Infants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Stress
Enteral Feeding Intolerance
Keywords: body position
enteral feeding intolerance
nursing care
pain
stress
Lead sponsor: Pamukkale University
Sponsor class: OTHER
First posted: 2019-11-07
Enrollment: 34
Sex: ALL
Minimum age (years): 30
Maximum age (years): 34
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Neonatal pain
timeFrame: Four month
measure: Neonatal stress
timeFrame: Four month
measure: Feeding intolerance
timeFrame: Four month
Secondary outcomes:
measure: Heart Rate
timeFrame: Four month
measure: Oxygen Saturation
timeFrame: Four month
measure: Respiratory Rate
timeFrame: Four month
Other outcomes:
Locations:
city: Denizli
country: Turkey
facility: Sibel Serap Ceylan
Study officials:
affiliation: Pamukkale Univesity
name: Sibel Serap Ceylan
role: STUDY_DIRECTOR
References:
citation: Khatony A, Abdi A, Karimi B, Aghaei A, Brojeni HS. The effects of position on gastric residual volume of premature infants in NICU. Ital J Pediatr. 2019 Jan 8;45(1):6. doi: 10.1186/s13052-018-0591-9.
citation: Dsilna A, Christensson K, Gustafsson AS, Lagercrantz H, Alfredsson L. Behavioral stress is affected by the mode of tube feeding in very low birth weight infants. Clin J Pain. 2008 Jun;24(5):447-55. doi: 10.1097/AJP.0b013e3181633fd6.