Heart And Lung Failure - Pediatric INsulin Titration Trial

ClinicalTrials.gov ID: NCT01565941

Public ClinicalTrials.gov record NCT01565941. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

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ClinicalTrials.gov public records Last synced Oct 30, 2026, 1:34 AM EDT

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Official title

Heart And Lung Failure - Pediatric INsulin Titration Trial (HALF-PINT)

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

Stress hyperglycemia, a state of abnormal metabolism with supra-normal blood glucose levels, is often seen in critically ill patients. Tight glycemic control (TGC) was originally shown to reduce morbidity and mortality in a landmark randomized clinical trial (RCT) of adult critically ill surgical patients but has since come under intense scrutiny due to conflicting results in recent adult trials. One pediatric RCT has been published to date that demonstrated survival benefit but was complicated by an unacceptably high rate of severe hypoglycemia. The Heart And Lung Failure - Pediatric INsulin Titration (HALF-PINT) trial is a multi-center, randomized clinical treatment trial comparing two ranges of glucose control in hyperglycemic critically ill children with heart and/or lung failure. Both target ranges of glucose control fall within the range of "usual care" for critically ill children managed in pediatric intensive care units. The purpose of the study is to determine the comparative effectiveness of tight glycemic control to a target range of 80-110 mg/dL (TGC-1, 4.4-6.1 mmol/L) vs. a target range of 150-180 mg/dL (TGC-2, 8.3-10.0 mmol/L) on hospital mortality and intensive care unit (ICU) length of stay (LOS) in hyperglycemic critically ill children with cardiovascular and/or respiratory failure. This will be accomplished using an explicit insulin titration algorithm and continuous glucose monitoring to safely achieve these glucose targets. Both groups will receive identical standardized intravenous glucose at an age-appropriate rate in order to provide basal calories and mitigate hypoglycemia. Insulin infusions will be titrated with an explicit algorithm combined with continuous glucose monitoring using a protocol that has been safely implemented in 490 critically ill infants and children.

Study identification

NCT ID: NCT01565941
Recruitment status: Completed
Study type: Interventional
Phase: Phase 3
Lead sponsor: Boston Children's Hospital; Other
Enrollment: 713 participants

Conditions and interventions

Conditions

Interventions

Insulin Drug

Drug

Eligibility (public fields only)

Age range: 2 Weeks to 17 Years
Sex: All
Healthy volunteers: Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Apr 2012 (Actual)
Primary completion: Sep 2016 (Actual)
Completion: Feb 2018 (Actual)
Last update posted: Jul 25, 2022

2012 – 2018

United States locations

U.S. sites: 33
U.S. states: 20
U.S. cities: 29

Facility	City	State	ZIP	Site status
Miller Children's Hospital Long Beach	Long Beach	California	90806	—
Children's Hospital of Los Angelos	Los Angeles	California	90027	—
Mattel Children's Hospital	Los Angeles	California	90095	—
Children's Hospital & Research Center of Oakland	Oakland	California	94609	—
Children's Hospital of Orange County	Orange	California	92868	—
UCSF Benioff Children's Hospital	San Francisco	California	94143	—
Children's Hospital Colorado	Aurora	Colorado	80045	—
Yale-New Haven Children's Hospital	New Haven	Connecticut	06520	—
Nemours/A.I DuPont Hospital for Children	Wilmington	Delaware	19803	—
Children's Healthcare of Atlanta	Atlanta	Georgia	30322	—
Ann & Robert H. Lurie Children's Hospital pf Chicago	Chicago	Illinois	60611	—
University of Chicago Comer Children's Hospital	Chicago	Illinois	60637	—
University of Louisville	Louisville	Kentucky	40202	—
University of Maryland Medical Center	Baltimore	Maryland	21201	—
Johns Hopkins Hospital	Baltimore	Maryland	21287	—
Boston Children's Hospital	Boston	Massachusetts	02115	—
C.S. Mott Children's Hospital	Ann Arbor	Michigan	48109	—
St. Louis Children's Hospital	St Louis	Missouri	63110	—
Dartmouth Hitchcock Medical Center	Lebanon	New Hampshire	03755	—
Women and Children's Hospital of Buffalo	Buffalo	New York	14222	—
North Shore LIJ Cohen Children's Medical Center	New Hyde Park	New York	11040	—
Morgan Stanley Children's Hospital of New York	New York	New York	10032	—
The Children's Hospital at Montefiore	The Bronx	New York	10467	—
Westchester Medical Center	Valhalla	New York	10595	—
Duke Children's Hospital and Medical Center	Durham	North Carolina	27705	—
Cincinnati Children's Hospital	Cincinnati	Ohio	45229	—
The Children's Hospital at OU Medical Center	Oklahoma City	Oklahoma	73104	—
Penn State Hershey Medical Center	Hershey	Pennsylvania	17033	—
Children's Hospital of Philadelphia	Philadelphia	Pennsylvania	19104	—
Medical City Children's Dallas	Dallas	Texas	75230	—
Children's Medical Center Dallas	Dallas	Texas	75235	—
Primary Children's Hospital	Salt Lake City	Utah	84113	—
Seattle Children's Hospital	Seattle	Washington	98105	—

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 2 non-U.S. sites.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT01565941, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Jul 25, 2022 · Synced Oct 30, 2026

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