NCT04156529

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
34

participants targeted

Target at below P25 for not_applicable pain

Timeline
Completed

Started May 2019

Shorter than P25 for not_applicable pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 6, 2019

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 15, 2019

Completed
13 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 28, 2019

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 11, 2019

Completed
27 days until next milestone

First Posted

Study publicly available on registry

November 7, 2019

Completed
Last Updated

November 8, 2019

Status Verified

November 1, 2019

Enrollment Period

3 months

First QC Date

October 11, 2019

Last Update Submit

November 7, 2019

Conditions

PainStressEnteral Feeding Intolerance

Keywords

body positionenteral feeding intolerancenursing carepainstress

Outcome Measures

Primary Outcomes (3)

  • Neonatal pain

    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.

    Four month

  • Neonatal stress

    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.

    Four month

  • Feeding intolerance

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

    Four month

Secondary Outcomes (3)

  • Heart Rate

    Four month

  • Oxygen Saturation

    Four month

  • Respiratory Rate

    Four month

Study Arms (2)

ESU position

EXPERIMENTAL

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

Behavioral: ESU positionBehavioral: ESRL position

ESRL position

EXPERIMENTAL

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

Behavioral: ESU positionBehavioral: ESRL position

Interventions

ESU positionBEHAVIORAL

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

ESRL positionESU position
ESRL positionBEHAVIORAL

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

ESRL positionESU position

Eligibility Criteria

Age30 Weeks - 34 Weeks
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • weeks gestational age,
  • stable vital signs,
  • no oral feeding skills,
  • feeding by orogastric tube,
  • had parental consent

You may not qualify if:

  • respiratory distress,
  • congenital anomalies,
  • necrotizing enterocolitis history,
  • neurological and cardiological problems,
  • receiving analgesic, sedative, or muscle relaxant medication that may affect pain and stress

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sibel Serap Ceylan

Denizli, 20100, Turkey (Türkiye)

Location

Related Publications (2)

  • 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.

    PMID: 30621733RESULT

  • 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.

    PMID: 18496310RESULT

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Sibel Serap Ceylan

    Pamukkale Univesity

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 11, 2019

First Posted

November 7, 2019

Study Start

May 6, 2019

Primary Completion

August 15, 2019

Study Completion

August 28, 2019

Last Updated

November 8, 2019

Record last verified: 2019-11

Locations

TU(1)