Sweetheart Study: Oral Glucose for Reducing Stress During Echocardiographic Assessment in Infants in the NICU

NCT ID: NCT01253889

Last Updated: 2017-02-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 104 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-12-31
• Study Completion Date: 2013-06-30

Brief Summary

The purpose of this study is to compare the effect of a 25% glucose solution given via a soother with or without facilitated tucking with a similarly administered water placebo (control condition) on infant stress responses during and immediately after a neonatologist performed ECHO (np-ECHO).

Detailed Description

One hundred and four infants were randomized to one of four groups during a single np-ECHO examination, at the discretion of the medical team. Randomization to soother and water (Control) with and without facilitated tucking or to soother and 25% glucose (Intervention) with or without facilitated tucking will be determined by generating randomly permuted sequential blocks of four and six allocation numbers.

Conditions

Cardiac Echocardiography Assessment

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Oral Glucose with soother

Oral Glucose 25% first given two minutes before the first contact by the physician performing the np-ECHO. A soother will be held in the infant's mouth to ensure that continuous contact is maintained throughout the testing period. Repeat application of solution as per study protocol. No other non-pharmaceutical interventions for stress reduction will be applied. During each np-ECHO, infants have additional handling only if it is required to maintain physiological stability.

Group Type: ACTIVE_COMPARATOR

Glucose 25% oral solution

Intervention Type: DRUG

0.5ml of 25% glucose (26-31 weeks gestational age group) or 1.0 ml of 25% glucose (32-42 weeks gestational age group). This application can be repeated if necessary to a maximum of four times, adding up to max 2ml of 25% glucose in the 26-31 weeks gestational age group or 4ml of 25% glucose in the 32-42 weeks gestational age group.

Oral water with soother

Oral water first given two minutes before the first contact by the physician performing the np-ECHO. A soother will be held in the infant's mouth to ensure that continuous contact is maintained throughout the testing period. Repeat application of solution as per study protocol. No other non-pharmaceutical interventions for stress reduction will be applied. During each np-ECHO, infants have additional handling only if it is required to maintain physiological stability.

Group Type: PLACEBO_COMPARATOR

Oral water

Intervention Type: OTHER

0.5ml of oral water (26-31 weeks gestational age group) or 1.0 ml of oral water (32-42 weeks gestational age group). This application can be repeated if necessary to a maximum of four times, adding up to max 2ml of oral water in the 26-31 weeks gestational age group or 4ml of oral water in the 32-42 weeks gestational age group.

Oral glucose with soother and tucking

For the infants randomized to receive facilitated tucking throughout the procedure, the bedside nurse will provide gentle, firm containment of the extremities. The facilitated tucking will commence immediately after the baseline BIIP score is taken, but before the glucose/water is administered.

Group Type: ACTIVE_COMPARATOR

Glucose 25% oral solution

Intervention Type: DRUG

0.5ml of 25% glucose (26-31 weeks gestational age group) or 1.0 ml of 25% glucose (32-42 weeks gestational age group). This application can be repeated if necessary to a maximum of four times, adding up to max 2ml of 25% glucose in the 26-31 weeks gestational age group or 4ml of 25% glucose in the 32-42 weeks gestational age group.

Oral water with soother and tucking

For the infants randomized to receive facilitated tucking throughout the procedure, the bedside nurse will provide gentle, firm containment of the extremities. The facilitated tucking will commence immediately after the baseline BIIP score is taken, but before the glucose/water is administered.

Group Type: PLACEBO_COMPARATOR

Oral water

Intervention Type: OTHER

0.5ml of oral water (26-31 weeks gestational age group) or 1.0 ml of oral water (32-42 weeks gestational age group). This application can be repeated if necessary to a maximum of four times, adding up to max 2ml of oral water in the 26-31 weeks gestational age group or 4ml of oral water in the 32-42 weeks gestational age group.

Interventions

Glucose 25% oral solution

0.5ml of 25% glucose (26-31 weeks gestational age group) or 1.0 ml of 25% glucose (32-42 weeks gestational age group). This application can be repeated if necessary to a maximum of four times, adding up to max 2ml of 25% glucose in the 26-31 weeks gestational age group or 4ml of 25% glucose in the 32-42 weeks gestational age group.

Intervention Type: DRUG

Oral water

0.5ml of oral water (26-31 weeks gestational age group) or 1.0 ml of oral water (32-42 weeks gestational age group). This application can be repeated if necessary to a maximum of four times, adding up to max 2ml of oral water in the 26-31 weeks gestational age group or 4ml of oral water in the 32-42 weeks gestational age group.

Intervention Type: OTHER

Other Intervention Names

glucose

Eligibility Criteria

Inclusion Criteria

• Infants born between 26-42 weeks of gestational age admitted to the Neonatal Intensive Care Unit who require a np-ECHO for clinical purposes as indicated by the medical team.

Exclusion Criteria

• Infants who have congenital anomalies, or a lethal condition in whom intensive care is not indicated;
• Infants below the gestational age of 26 completed weeks;
• Infants who have received analgesics or sedatives within 72 hours of the assessment;
• History of maternal abuse of controlled drugs and substances.
• Infants who are too unstable to receive oral medications or be exposed to a np-ECHO or who already have had an ECHO performed by a Pediatric Cardiologist within 4 hours.

• Maximum Eligible Age: 6 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Children's & Women's Health Centre of British Columbia

OTHER

Sponsor Role: lead

Responsible Party

Liisa Holsti

Tier 2 Canada Research Chair in Neonatal Health and Development

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Children's & Women's Health Centre of BC

Vancouver, British Columbia, Canada

Countries

Canada

References

Lavoie PM, Stritzke A, Ting J, Jabr M, Jain A, Kwan E, Chakkarapani E, Brooks P, Brant R, McNamara PJ, Holsti L. A Randomized Controlled Trial of the Use of Oral Glucose with or without Gentle Facilitated Tucking of Infants during Neonatal Echocardiography. PLoS One. 2015 Oct 23;10(10):e0141015. doi: 10.1371/journal.pone.0141015. eCollection 2015.

Reference Type: DERIVED

PMID: 26496361 (View on PubMed)

Other Identifiers

H10-02069

Identifier Type: -

Identifier Source: org_study_id