Effects of the Different Concentrations of Oral Dextrose Solution Applying With Supportive Positions on Pain During Heel-Stick Sampling in Premature Infants

NCT05177263 | Completed

• 1 other identifier: MersinU*GUGUCU_002
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 1

Brief Summary

Within the scope of the newborn screening (metabolic and endocrine diseases) tests (NSTs), this research aims to determine the effect of the different concentrations of oral dextrose solution applying together with supportive positions primarily on the pain scores and secondarily on the duration of crying time during the heel-stick sampling in premature infants.

Conditions

Pain

Outcome Measures

Primary Outcomes (3)

• Pain will be measured by N-PASS

  It is scored with 0 to 2 points available for each criterion (crying/irritability, behavioral state, facial expression, extremity tone and vital signs) and ranged from 0 to 10. Higher values represent higher pain.

  at the heel punction during heel-stick sampling

• Pain will be measured by N-PASS

  It is scored with 0 to 2 points available for each criterion (crying/irritability, behavioral state, facial expression, extremity tone and vital signs) and ranged from 0 to 10. Higher values represent higher pain.

  at 1st minute after the heel punction

• Pain will be measured by N-PASS

  It is scored with 0 to 2 points available for each criterion (crying/irritability, behavioral state, facial expression, extremity tone and vital signs) and ranged from 0 to 10. Higher values represent higher pain.

  at 2st minute after the heel punction

Secondary Outcomes (1)

• Duration of crying will be documented by video recordings

  The total crying time is measured from where it starts until the over.

Other Outcomes (1)

• Number of Participants with Adverse Events

  Within 2 minutes following the procedure and oral solution

Study Arms (4)

Supportive Positions + Oral Sterile Water

PLACEBO COMPARATOR

The enrolled premature infants will be administered 1ml of the sterile water a first time 2 minutes before the procedure. After 2 minutes, heel-stick sampling (with an auto lancet for premature infants) will be performed immediately after administering 1 ml of sterile water a second time.

Other: Placebo

Supportive Positions + 10% Oral Dextrose

ACTIVE COMPARATOR

The enrolled premature infants will be administered 1ml of the 10% oral dextrose solution a first time 2 minutes before the procedure. After 2 minutes, heel-stick sampling (with an auto lancet for premature infants) will be performed immediately after administering 1 ml of 10% oral dextrose solution a second time. (%10 oral dextrose solution: osmolarity= 550 mOsm/L, pH= 3.5-6.5, calorie=400 kcal/L)

Drug: 10% Oral Dextrose Solution

Supportive Positions + 20% Oral Dextrose

ACTIVE COMPARATOR

The enrolled premature infants will be administered 1ml of the 20% oral dextrose solution a first time 2 minutes before the procedure. After 2 minutes, heel-stick sampling (with an auto lancet for premature infants) will be performed immediately after administering 1 ml of 20% oral dextrose solution a second time. (%20 oral dextrose solution: osmolarity= 1010 mOsm/L, pH= 3.2-6.5, calorie= 680 kcal/L)

Drug: 20% Oral Dextrose Solution

Supportive Positions + 30% Oral Dextrose

ACTIVE COMPARATOR

The enrolled premature infants will be administered 1ml of the 30% oral dextrose solution a first time 2 minutes before the procedure. After 2 minutes, heel-stick sampling (with an auto lancet for premature infants) will be performed immediately after administering 1 ml of 30% oral dextrose solution a second time. (%30 oral dextrose solution: osmolarity= 1515 mOsm/L, pH= 3.2-6.5, calorie= 1020 kcal/L)

Drug: 30% Oral Dextrose Solution

Interventions

Placebo OTHER

Sterile Water

Supportive Positions + Oral Sterile Water

10% Oral Dextrose Solution DRUG

10% Oral Dextrose Solution

Also known as: Sweet taste

Supportive Positions + 10% Oral Dextrose

20% Oral Dextrose Solution DRUG

20% Oral Dextrose Solution

Also known as: Sweet taste

Supportive Positions + 20% Oral Dextrose

30% Oral Dextrose Solution DRUG

30% Oral Dextrose Solution

Also known as: Sweet taste

Supportive Positions + 30% Oral Dextrose

Eligibility Criteria

• Age: 2 Days - 7 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Gestational age (GA) at birth 33+0 - 37+0 weeks
• Admitted to NICU
• Planned the heel-stick sampling within the scope of the NSTs
• Parents are able to read, write and speak Turkish

You may not qualify if:

• With a postnatal age of 8 days or more
• Has contraindications for the administration of oral glucose (genetic, endocrine, metabolic diseases or neurological problems etc.)
• Has major congenital anomalies
• Has intubated or receiving a nCPAP
• Has received analgesics or sedatives for less than 24 hours before the procedure

Sponsors & Collaborators

• Guzide UGUCU: lead

Study Sites (1)

Mersin University Hospital

Mersin, Yenişehir, 33, Turkey (Türkiye)

Location

Related Publications (1)

• Ugucu G, Yigit R, Celik Y. Effect of combining oral glucose solutions with supportive positions on pain during heel puncture blood sampling in premature infants: A randomized quadruple-blinded experimental study. J Pediatr Nurs. 2024 Jul-Aug;77:e108-e116. doi: 10.1016/j.pedn.2024.03.038. Epub 2024 Apr 3.

  PMID: 38570229 RESULT

MeSH Terms

Conditions

Pain

Interventions

Gurmarin protein, Gymnema sylvestre

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Guzide UGUCU

  Mersin University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The opaque envelopes are stored in a locked cabinet by the researcher who performed the randomization. The group including the eligible premature infants will not be shared care provider and assessors. Parents will be masked to the groups. Data entries will be performed using the codes A, B, C, and D. Codes will be shared with the researchers after statistical analyses are conducted and the research report is written.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Res. Asst., RN, MScN, PhD Candidate

Study Record Dates

• First Submitted: December 15, 2021
• First Posted: January 4, 2022
• Study Start: June 6, 2022
• Primary Completion: June 8, 2023
• Study Completion: September 1, 2023
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)