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CompletedNCT07467616PED-DKAUpdated Mar 12, 2026

Impact of Clinical Nursing Guideline on Outcomes of Children With Diabetic Ketoacidosis.

An interventional study of Evidence-Based Nursing Guideline for Children with Diabetic Ketoacidosos in Diabetic Ketoacidosis, sponsored by Hawler Medical University. Completed at 1 site in Iraq. Open to participants aged 6 Years to 16 Years. Per ClinicalTrials.gov, last updated 2026-03-12.

Sponsored by Hawler Medical University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 9 months after the study started (first participant enrolled May 2025, registered Mar 2026).
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Non-randomized
Ages
6 Years to 16 Years
Sex
All
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Study summary

Diabetic ketoacidosis (DKA) is a serious and potentially life-threatening complication of diabetes mellitus in children and requires timely and structured management to prevent morbidity and mortality. Inconsistency in clinical practice and delayed recognition of complications may negatively affect patient outcomes. Evidence-based clinical nursing guidelines can improve the quality and consistency of care provided to children with DKA.

This study aimed to assess the impact of an evidence-based nursing guideline on clinical outcomes among children diagnosed with diabetic ketoacidosis. A quasi-experimental study design was used, including two groups: a control group receiving routine hospital care and an intervention group receiving care based on an evidence-based nursing guideline.

The guideline included structured nursing assessment, continuous monitoring of vital signs and neurological status, blood glucose monitoring, fluid balance monitoring, and early detection and management of complications. Clinical outcomes including blood glucose level, blood pH, neurological status, and duration of hospital stay were compared between the control and intervention groups.

Read the detailed description

Diabetic ketoacidosis is one of the most common acute complications of diabetes mellitus in pediatric patients and remains a major cause of morbidity and hospital admission among children with diabetes. Effective management requires careful monitoring of metabolic status, fluid therapy, insulin administration, and early detection of complications such as cerebral edema and electrolyte imbalance.

Evidence-based nursing practice plays an essential role in improving the quality of care and patient safety during the management of pediatric diabetic ketoacidosis. Implementation of standardized clinical nursing guidelines can enhance clinical decision-making, improve monitoring of patients, and promote early identification of complications.

This study was conducted to assess the effectiveness of implementing an evidence-based clinical nursing guideline on clinical outcomes among children diagnosed with diabetic ketoacidosis. A quasi-experimental study design was used. Children admitted with diabetic ketoacidosis were divided into a control group receiving routine hospital management and an intervention group receiving care according to an evidence-based nursing guideline.

The guideline included structured monitoring of vital signs, neurological assessment using the Glasgow Coma Scale, frequent blood glucose monitoring, fluid balance monitoring, electrolyte monitoring, and nursing interventions aimed at early detection and prevention of complications.

Clinical outcomes evaluated in this study included blood glucose level, blood pH level, neurological status, and length of hospital stay. The findings of this study are expected to provide evidence regarding the effectiveness of structured nursing guidelines in improving the management and clinical outcomes of pediatric patients with diabetic ketoacidosis.

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Conditions studied

  • Diabetic Ketoacidosis

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Keywords

  • Pediatric Diabetic Ketoacidosis
  • Evidence-Based Nursing Guideline
  • Type I Diabetic
  • Pediatric Emergency Care
  • Pediatric Critical Care Nursing
  • Management of Diabetic Ketoacidosis
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In context

Diabetic Ketoacidosis

80 studies on the registry are indexed under Diabetic Ketoacidosis; 15 are open to participants now.

This study's enrollment of 60 is close to the median of 59 across 46 interventional studies indexed under Diabetic Ketoacidosis.

Browse Diabetic Ketoacidosis studies →

Lead sponsor

Hawler Medical University is the lead sponsor of 56 studies on the registry; 6 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
6 Years to 16 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Children age from 6-16 years old.
  • Both sexes.
  • Have not other critical medical condition that interfere with study.
  • Diagnosed with diabetic ketoacidosis.
  • Have the ability to participate and accept to participate in the study.

Exclusion criteria

Exclusion Criteria:

  • Children with comorbid chronic illnesses like congenital heart disease, renal failure, etc.
  • Recurrent admission during the same study period (only first admission considered).
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
60 participants (actual)

Study arms

  • No intervention
    Control Group

    Children with diabetic ketoacidosis who received routine hospital management according to standard hospital protocol without implementation of the evidence-based nursing guideline.

  • Other
    Intervention Group

    Children with diabetic ketoacidosis who received care according to an evidence-based clinical nursing guideline including structured monitoring of vital signs, neurological assessment, blood glucose monitoring, fluid balance monitoring, and early detection and management of complications.

    Other: Evidence-Based Nursing Guideline for Children with Diabetic Ketoacidosos

Interventions

  • OtherEvidence-Based Nursing Guideline for Children with Diabetic Ketoacidosos

    Implementation of an evidence-based clinical nursing guideline for the management of children with diabetic ketoacidosis. The guideline includes structured nursing assessment, continuous monitoring of vital signs and neurological status using the Glasgow Coma Scale, frequent blood glucose monitoring, fluid balance monitoring, electrolyte monitoring, and nursing interventions aimed at early detection and management of complications during DKA treatment.

06

What researchers measure

Primary outcomes

  1. Resolution Time of Diabetic ketoacidosis

    Time required for resolution of diabetic ketoacidosis measured from hospital admission until normalization of metabolic parameters including blood glucose level, blood pH, and serum bicarbonate according to standard pediatric DKA management criteria.

    Time frame: From the time of hospital admission until normalization of metabolic parameters indicating resolution of diabetic ketoacidosis, assessed up to 48 hours.

Secondary outcomes

  1. Blood glucose level

    Change in blood glucose level during treatment of DKA, unitl return to normal standard level.

    Time frame: From hospital admission to 48 hours after initiation of treatment

  2. Length of hospital stay

    Total duration of hospital stay measured in days from admission until discharge of child to home.

    Time frame: From hospital admission until hospital discharge, with follow-up assessment conducted up to 2 months after discharge

07

Study locations

1 site
  • Raparin Pediatric Teaching Hospital
    Erbil, Kurdistan Region 44001, Iraq
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References and documents

Publications

  • Wright N, Thomas R. BSPED guideline: what we know and why the guideline was changed. Arch Dis Child Educ Pract Ed. 2021 Aug;106(4):226-228. doi: 10.1136/archdischild-2020-320077. Epub 2021 Mar 3. No abstract available. PubMed 33658290 ↗

Individual participant data

Plan to share: No — ndividual participant data collected during the study will not be publicly shared due to institutional policies and ethical considerations related to patient confidentiality. Aggregated results will be reported in publications and academic reports.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 12, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07467616
Lead sponsor
Hawler Medical University
Responsible party
Khaleed Mohammed Shaikhah (Principal Investigator, Hawler Medical University) — Principal investigator
First posted
Mar 12, 2026
Start date
May 14, 2025
Primary completion
Dec 1, 2025
Completion
Feb 1, 2026
Last update
Mar 12, 2026

Study contacts

Khaleed M Shaikhah, MSc
principal investigator · Hawler Medical University/ College of Nursing

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.

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