Stress Hydrocortisone In Pediatric Septic Shock (SHIPSS)

SHIPSS is a multi-institutional, prospective, controlled, randomized, double-blinded interventional trial that will examine the potential benefits and risks of adjunctive hydrocortisone prescribed for children with fluid and vasoactive-inotropic refractory septic shock.

It is hypothesized that adjunctive hydrocortisone will significantly reduce the incidence of new and progressive organ dysfunction (primary outcome) and proportion of children with poor outcomes, defined as death or severely impaired health-related quality of life (HRQL) (secondary outcome), as assessed at 28 days following study enrollment (randomization).

Study Overview

• Status: Recruiting
• Conditions: Septic Shock
• Intervention / Treatment: Drug: Hydrocortisone, sodium succinate; Drug: Normal saline

Detailed Description

Sepsis represents the most common cause of childhood mortality worldwide. In the United States alone, 200 cases of pediatric sepsis are diagnosed each day, with an associated hospital mortality rate of 5-10% and health care expenditures now approaching $5 billion annually. Moreover, nearly one third of children admitted to pediatric intensive care units (PICUs) for septic shock have not regained their baseline health-related quality of life one year following the sepsis event.

During early resuscitation of the child with septic shock, in addition to antibiotics, volume replacement, and vasoactive-inotropic support, the most recent pediatric treatment guidelines advise the practitioner to consider adjunctive hydrocortisone therapy if the patient "is at risk of absolute adrenal insufficiency or adrenal pituitary axis failure". However, the potential benefits and risks of this recommendation have not been rigorously examined. On the one hand, corticosteroids are inexpensive and have been frequently demonstrated to improve hemodynamic status in children and adults with sepsis. Conversely, this drug class is known to alter transcription of approximately 30% of the human genome. Notably, corticosteroids down regulate most aspects of the immune response, but particularly adaptive immunity. Moreover, recent data suggests that children with particular gene expression profiles in sepsis have increased likelihood of mortality when treated with corticosteroids.

SHIPSS (Stress Hydrocortisone In Pediatric Septic Shock) is a prospective, randomized, double-blinded, placebo-controlled trial examining the potential benefits and risks of adjunctive hydrocortisone prescribed to critically ill children with fluid and vasoactive-inotropic refractory septic shock. Up to 500 children will be enrolled, randomized, and evaluated at baseline, and 28 and 90 days following study enrollment.

The primary hypothesis is that hydrocortisone, compared to placebo, will decrease the the incidence of new or progressive organ dysfunction (primary outcome) and the proportion of subjects with poor outcomes, defined as death or severely impaired (≥25% decrease from baseline) HRQL (secondary outcome). Subjects will be monitored daily while receiving care in the PICU for the occurrence of adverse events, including the following protocol specified events:hyperglycemia treated with any insulin; gastrointestinal hemorrhage treated with blood product transfusion or vasopressin or octreotide infusion; delirium requiring medical treatment; and hospital-acquired infection treated with new antimicrobials. Finally, the investigators will test the hypothesis that biomarker-based prognostic and predictive enrichment strategies can improve our ability to identify which children with septic shock are more likely to benefit from adjunctive hydrocortisone, and which may be harmed. This trial will have a significant impact on public health by providing the heretofore missing evidence to inform guidelines regarding therapy for septic shock in children.

The SHIPSS trial will enroll patients from PICUs in Canada, the United States, Saudi Arabia, Israel, Brazil, Vietnam, Pakistan, Japan, Malaysia, and Singapore. Health Canada approval is not required as hydrocortisone is approved for use in septic shock in children, and this trial meets the criteria of a Phase IV study. In the United States, this trial is considered a Phase III trial as hydrocortisone is not approved for use in pediatric septic shock.

• Study Type: Interventional
• Enrollment (Estimated): 500
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Jerry J Zimmerman, MD, PhD; Phone Number: 206-987-3862; Email: jerry.zimmerman@seattlechildrens.org
• Study Contact Backup: Name: Kusum Menon, MD, MSc; Phone Number: 2538 613-737-7600; Email: menon@cheo.on.ca

Study Locations

• Brazil
  • Bahia, Brazil
    • Recruiting
    • Santa Casa de Misericórdia da Bahia
    • Contact: Rosana Novais de Carvalho, MD; Email: rosana.carvalho@santacasaba.org.br
  • Rio de Janeiro, Brazil
    • Recruiting
    • Hospital Jutta Batista - Rio de Janeiro
    • Contact: Arnaldo Prata Barbosa, MD; Email: arnaldo.prata@idor.org
    • Contact: Maria Carvalho Laborne Valle, MD; Email: maria.valle@rededor.com.br
• Canada
  • Alberta
    • Calgary, Alberta, Canada, T3B 6A8
      • Recruiting
      • Alberta Children's Hospital
      • Contact: Megan Mahoney, MD
  • British Columbia
    • Vancouver, British Columbia, Canada, V6H 3N1
      • Terminated
      • BC Children's Hospital
  • Nova Scotia
    • Halifax, Nova Scotia, Canada, B3K 6R8
      • Recruiting
      • IWK Health Centre
      • Contact: Neeraj Verma, MD
  • Ontario
    • Hamilton, Ontario, Canada, L8N 3Z5
      • Recruiting
      • McMaster Children's Hospital
      • Contact: Karen Choong, MD
    • London, Ontario, Canada, N6A 5W9
      • Recruiting
      • London Health Sciences Centre
      • Contact: Douglas Fraser, MD
    • Ottawa, Ontario, Canada, K1H 8L1
      • Recruiting
      • Children's Hospital of Eastern Ontario
      • Contact: Katie O'Hearn, MSc; Phone Number: 4006 613-737-7600; Email: kohearn@cheo.on.ca
      • Contact: Kusum Menon, MD; Phone Number: 2538 613-737-7600; Email: menon@cheo.on.ca
      • Sub-Investigator: James D McNally, MD, PhD
  • Quebec
    • Montreal, Quebec, Canada, H3T 1C5
      • Recruiting
      • Centre Hospitalier Universitaire Sainte-Justine
      • Contact: Marisa Tucci, MD
    • Montreal, Quebec, Canada, H4A 3J1
      • Terminated
      • Montreal Children's Hospital
    • Québec, Quebec, Canada, G1V 4G2
      • Recruiting
      • Centre hospitalier de l'Université Laval
      • Contact: Matthew Weiss, MD
  • Saskatchewan
    • Saskatoon, Saskatchewan, Canada, S7K 1M6
      • Terminated
      • Royal University Hospital
• Israel
  • Haifa, Israel
    • Not yet recruiting
    • Rambam Health Care Campus
    • Contact: Amir Hadash, MD
  • Jerusalem, Israel
    • Not yet recruiting
    • Hadassah University Medical Center, Ein Kerem
    • Contact: Asaf Mandel, MD
  • Petah Tikva, Israel
    • Not yet recruiting
    • Schneider Children's Medical Center of Israel
    • Contact: Elhanan Nahum, PhD
• Japan
  • Kobe, Japan
    • Recruiting
    • Kobe Children's Hospital
    • Contact: Hiroshi Kurosawa, MD
  • Nagoya, Japan
    • Recruiting
    • Aichi Children's Health and Medical Center
    • Contact: Takanari Ikeyama, MD
• Malaysia
  • Kuala Lumpur, Malaysia
    • Not yet recruiting
    • UKM Specialist Children's Hospital
    • Contact: Swee Fong Tang, MD
  • Kuala Lumpur, Malaysia
    • Recruiting
    • University Malaya Medical Centre
    • Contact: Chin Seng Gan, MD
  • Kuching, Malaysia
    • Not yet recruiting
    • Sarawak General Hospital
    • Contact: Olive Pei Ee Lee, MD
• Pakistan
  • Islamabad, Pakistan
    • Recruiting
    • Shifa International hospital
    • Contact: Humaira Rafique, MD
    • Contact: Ejaz Ahmed Khan, MD
  • Karachi, Pakistan
    • Recruiting
    • Aga Khan University Hospital
    • Contact: Qalab Abbas, MD
• Saudi Arabia
  • Riyadh, Saudi Arabia
    • Recruiting
    • King Abdullah Specialist Children's Hospital
    • Contact: Yasser Kazzaz, MD
• Singapore
  • Singapore, Singapore
    • Recruiting
    • KK Women's and Children's Hospital
    • Contact: Lee Jan Hau, MD
    • Contact: Loh Sin Wee, MD
• United States
  • Arizona
    • Tucson, Arizona, United States, 85724
      • Recruiting
      • University of Arizona Medical Centre
      • Contact: Katri Typpo, MD
  • California
    • Los Angeles, California, United States, 90027
      • Recruiting
      • Children's Hospital of Los Angeles
      • Contact: Christopher Newth, MD
    • Oakland, California, United States, 94609
      • Recruiting
      • UCSF Benioff Children's Hospital - Oakland
      • Contact: Natalie Cvijanovich, MD
    • Orange, California, United States, 92868
      • Recruiting
      • Children's Hospital of Orange County
      • Contact: Adam Schwarz, MD
    • San Francisco, California, United States, 94143
      • Recruiting
      • UCSF Benioff Children's Hospital - San Francisco
      • Contact: Matt Zinter, MD; Email: Matt.Zinter@ucsf.edu
      • Contact: Patrick McQuillen, MD; Email: McQuillP@ucsf.edu
  • Delaware
    • Wilmington, Delaware, United States, 19803
      • Recruiting
      • Nemours Children's Health
      • Contact: Catherine Madurski, MD
  • Illinois
    • Chicago, Illinois, United States, 60637
      • Recruiting
      • University of Chicago, Comer Children's Hospital
      • Contact: Grace Chong, MD
    • Peoria, Illinois, United States, 61603
      • Recruiting
      • The University of Illinois at Chicago/OSF Children's Hospital of Illinois
      • Contact: Sandeep Tripath, MD
  • Kentucky
    • Louisville, Kentucky, United States, 40202
      • Recruiting
      • University of Louisville, Norton Children's Hospital
      • Contact: John Berkenbosch, MD
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Recruiting
      • Boston Children's Hospital
      • Contact: Michael Agus, MD
  • New Jersey
    • Livingston, New Jersey, United States, 07039
      • Recruiting
      • Saint Barnabas Medical Center
      • Contact: Shira J Gertz, MD
  • Ohio
    • Cincinnati, Ohio, United States, 45229
      • Recruiting
      • Cincinnati Children's Hospital Medical Center
      • Contact: Ranjit R Chima, MD
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73104
      • Recruiting
      • The Children's Hospital at Oklahoma University Medical Center
      • Contact: Christine Allen, MD
  • Pennsylvania
    • Hershey, Pennsylvania, United States, 17033
      • Recruiting
      • Penn State Milton S. Hershey Children's Hospital
      • Contact: Robert Kavanagh, MD
  • Tennessee
    • Memphis, Tennessee, United States, 38163
      • Not yet recruiting
      • Le Bonheur Children's Hospital
      • Contact: Samir Shah, MD
  • Utah
    • Salt Lake City, Utah, United States, 84108
      • Recruiting
      • Primary Children's Hospital
      • Contact: Jennifer Workman, MD
  • Washington
    • Seattle, Washington, United States, 98105
      • Recruiting
      • Seattle Children's Hospital
      • Contact: Jerry J Zimmerman, MD, PhD
  • Wisconsin
    • Madison, Wisconsin, United States, 53792
      • Recruiting
      • University of Wisconsin Health/American Family Children's Hospital
      • Contact: Pelin Cengiz, MD
• Vietnam
  • Hanoi, Vietnam
    • Recruiting
    • Vietnam National Children's Hospital
    • Contact: Phuc Huu Phan, MD
  • Ho Chi Minh City, Vietnam
    • Not yet recruiting
    • City Children's Hospital
    • Contact: Nam Tran Nguyen, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 month to 17 years (Child)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

A child receiving treatment in a pediatric intensive care unit is eligible for recruitment into SHIPSS if she/he meets all of the following inclusion criteria:

1. Age is at least 1 month (with corrected gestational age ≥42 weeks), but less than 17 years and 8 months of age
2. A documented focus of infection or a strong suspicion of infection at PICU admission, or for patients who develop septic shock during PICU stay, at the onset of the septic shock event
3. Surveillance cultures (e.g. blood, urine, cerebral spinal fluid, wound) and/or other microbial diagnostic tests have been obtained
4. One or more antimicrobials have been prescribed
5. Core temperature >38.5 C or <36.0 C or leukocytosis or leukopenia (as defined by the local laboratory) or a left-shifted leukocyte differential (>10% immature granulocyte forms) or a neutrophil count of <0.5 x 109 cells per litre documented at least once within the 24 hours preceding screening
6. Treatment with a continuous infusion of vasoactive-inotropic agent(s) to maintain mean or systolic arterial blood pressure above the age-appropriate target set by the treating clinician
7. Administration of two or more vasoactive-inotropic agents at any dose or epinephrine or norepinephrine infusion(s) alone at greater than or equal to 0.10 mcg/kg/min for >1 hour.

Exclusion Criteria:

A child receiving treatment in a pediatric intensive care unit for sepsis is ineligible for enrollment into SHIPSS if she/he meets any of the following exclusion criteria:

1. All inclusion criteria have been present for > 12 hours
2. Attending physician expects to prescribe systemic corticosteroids for an indication other than septic shock
3. Patient has received any doses of systemic corticosteroids during treatment for sepsis
4. Enrolled concurrently in a competing interventional clinical trial (formal assessment to be conducted by SHIPSS Core Committee for each potential competing trial)
5. Etomidate or ketoconazole treatment within past 48 hours
6. Patient in whom steroids are contraindicated at time of screening (e.g. treatment for systemic fungal infection, cerebral malaria, strongyloides)
7. Known or suspected hypothalamic, pituitary or adrenal disease (including patient has received acute or chronic corticosteroid administration and the physician intends to provide corticosteroid for suspected adrenal suppression)
8. Attending physician, PICU care team, or legally recognized guardians not committed to full treatment and resuscitation at the time of screening
9. Patient documented to be pregnant
10. Previous enrollment in the SHIPSS study
11. Patient admitted directly to the PICU with a thermal burn who has been in the PICU for <72 hours prior to meeting SHIPSS inclusion criteria.
12. (U.S. sites only) Patient in the custody of US protective services
13. Patient being evaluated for brain death
14. Vasoactive-inotropic agents prescribed solely for an indication other than septic shock
15. Confirmed dengue fever

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Treatment; Approximately half of the subjects randomized into SHIPSS will be randomized into the Treatment Group and will receive hydrocortisone sodium succinate according to a predetermined dosing schedule.	Drug: Hydrocortisone, sodium succinate; Patients randomized to the hydrocortisone treatment arm will receive an initial bolus of 2 mg/kg IV hydrocortisone, followed by 1 mg/kg (maximum 50 mg) of hydrocortisone dosed every six hours for a maximum of seven days or until all vasoactive infusions have been discontinued for at least 12 hours, whichever comes first. When the hydrocortisone course is completed, the medication will be discontinued.; Other Names: SOLU-CORTEF- hydrocortisone sodium succinate injection
Placebo Comparator: Placebo; Approximately half of the subjects randomized into SHIPSS will be randomized into the Placebo Group and will receive equivalent study drug volumes of normal saline.	Drug: Normal saline; Patients randomized to the placebo treatment arm will receive an equivalent volume of normal saline, with the identical dosing schedule to the intervention (hydrocortisone) arm.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
New or progressive multiple organ dysfunction syndrome as assessed utilizing the Pediatric Logistic Organ Dysfunction (PELOD-2) instrument.	Appearance of new or progression of existing organ dysfunctions according to PELOD-2 definitions. PELOD-2 considers 5 organ dysfunctions (neurological, cardiovascular, renal, respiratory, and hematological) with 10 total variables, with dysfunction scored 0 up to 6 for each organ category. Total minimum/maximal scores are 0/33, with increasing score indicating increasing risk of mortality. Logit (mortality) = -6.61 + 0.47 × PELOD-2 score. Probability of death = 1/(1 + exp [-logit(mortality)]). A new organ dysfunction or progression of organ dysfunction is defined as an increase score in any organ category from baseline.	28 days following study enrollment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
28-day hospital mortality or ≥25% decrease from baseline in health-related quality of life (HRQL) assessed utilizing the Pediatric Quality of Life Inventory, (PedsQL)	Mortality or ≥25% decrease in PedsQL from baseline	28 days following study enrollment

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
SHIPSS specified adverse events	Occurrence of adverse events plausibly associated with corticosteroid administration. SHIPSS specified events include hyperglycemia, gastrointestinal hemorrhage, delirium, and hospital-acquired infection	28 days following study enrollment
Trichotomous mortality/morbidity outcome	This is a 3-level ordinal endpoint, with levels death, survival with severely impaired HRQL (≥25% decrease from baseline), and survival without severely impaired HRQL, assessed at 28 and 90 days. This approach is similar to that recently reported for assessment of functional status among children encountering critical illness, utilizing the Functional Status Scale. This endpoint is expected to be highly correlated with the primary efficacy endpoint.	28 and 90 days following study enrollment
90-Day Death or ≥25% decrease in HRQL from baseline	Mortality or ≥25% decrease in PedsQL from baseline	90 days following study enrollment
Vasoactive-inotropic infusion-free days through day 28	Vasoactive-inotropic infusion-free days through day 28 is defined as 28 minus duration of vasoactive-inotropic infusions. Subjects who die or are still receiving vasoactive-inotropic infusions by day 28 will be censored at 28 days and assigned zero vasoactive-inotropic infusion-free days.	28 days following study enrollment
Mechanical ventilation-free days through day 28	Mechanical ventilation-free days through day 28 is defined as 28 minus duration of mechanical ventilation. Subjects who die, are still receiving mechanical ventilation, or are transferred from the PICU still receiving mechanical ventilation by day 28 will be censored at 28 days and assigned zero mechanical ventilation-free days.	28 days following study enrollment
Utilization of acute renal replacement therapy (RRT)	Proportion of subjects receiving acute RRT. All types of acute RRT will be considered, including hemodialysis, continuous venovenous hemofiltration (CVVH), continuous venovenous hemodialysis (CVVHD), and peritoneal dialysis. RRT in patients on chronic RRT will not be considered.	Enrollment to PICU discharge, an average of 2 weeks
Utilization of extracorporeal membrane oxygenation (ECMO)	Proportion of subjects receiving ECMO	Enrollment to PICU discharge, an average of 2 weeks
Functional status - POPC	Gross functional status category staging will be made using the Pediatric Overall Performance Category (POPC) score.	28 and 90 days following study enrollment
Functional status - FSS	Functional Status Scale (FSS) will be employed to provide a more granular determination of changes in functional status.	28 and 90 days following study enrollment
PICU-free days through day 28	PICU-free days through day 28 is defined as 28 minus duration of PICU stay. Subjects who die or are still in the PICU by day 28 will be censored at 28 days and assigned zero PICU-free days.	28 days following study enrollment
Hospital-free days through day 28	Hospital-free days through day 28 is defined as 28 minus duration of hospital stay. Subjects who die or are still in the hospital by day 28 will be censored at 28 days and assigned zero hospital-free days through day 28.	28 days following study enrollment
Hospital-free days through day 90	Hospital-free days through day 90 is defined as 90 minus duration of hospital stay. Subjects who die or are still in the hospital by day 90 will be censored at 90 days and assigned zero hospital-free days through day 90.	90 days following study enrollment
Need for new medical devices at hospital discharge	New medical devices prescribed at hospital discharge will be collected from the hospital discharge summary.	At time of hospital discharge, expected to be an average of 21 days from time of enrollment
Frequency of primary care, specialty care, and emergency department visits and hospital readmissions	Enumeration of additional health care evaluations following the index hospital admission will occur by telephone survey at 90 days.	90 days following study enrollment
Disruption of family dynamics	The PedsQLTM 2.0 Family Impact Module will be used to quantify the impact of septic shock on family dynamics.	Enrollment and 90 days following study enrollment
Cost Analysis - Cost of PICU admission for septic shock	The cost of each patients PICU admission will be determined by summing the cost of the following: PICU and hospital length of stay, frequency of primary care, specialty care, emergency department visits, and hospital readmissions up to 90 days following hospital discharge, new medical devices post hospital discharge and hospital costs of the admission for septic shock.	90 days following study enrollment
Risk stratification sepsis biomarkers and pediatric sepsis endotype	Risk stratification sepsis biomarkers will be measured in serum obtained at enrollment and on Day 2. The PERSEVERE (PEdiatRic SEpsis biomarkEr Risk modEl) will be used to determine the patient's risk of mortality. mRNA will be isolated from blood samples collected at enrollment and on Day 2 to classify the patient as pediatric septic shock Endotype B or A. A composite outcome of sepsis endotype and PERSEVERE risk of mortality will be used to determine if a biomarker-based prognostic model and predictive enrichment strategies allow identification of children with septic shock more likely to benefit from adjunctive hydrocortisone. We hypothesize that pediatric septic shock "endotype B" subjects having an intermediate to high Pediatric Sepsis Biomarker Risk Model (PERSEVERE)-based risk of mortality will derive significant benefit from adjunctive corticosteroids, compared to endotype B subjects having a low risk and endotype A subjects at all risk levels.	Enrollment and Day 2

Collaborators and Investigators

• Sponsor: Jerry Zimmerman
• Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD); Canadian Institutes of Health Research (CIHR); Children's Hospital of Eastern Ontario; Canadian Critical Care Trials Group
• Investigators: Principal Investigator: Jerry J Zimmerman MD, MD, PhD, Seattle Children's Hospital, University of Washington School of Medicine; Principal Investigator: Michael Agus, MD, Boston Children's Hospital, Harvard Medical School; Principal Investigator: David Wypij, PhD, Boston Children's Hospital, Harvard Medical School; Principal Investigator: Kusum Menon, MD, MSc, Children's Hospital of Eastern Ontario; Principal Investigator: Mihir R Atreya, MD, MPH, Children's Hospital Medical Center, Cincinnati

Publications and helpful links

General Publications

• Basu S, Habet V, Delgado M, Chiu P, Knox D, Thibault E, Shukla A, Harrington E, Bailey V, Lipsitz S, Fu Y, Agus M, Kheir J, Sasaki J, Moynihan K. Adjunctive Corticosteroids for Hypotension in the Pediatric Cardiac ICU: Single-Center Retrospective Study, 2020-2021. Pediatr Crit Care Med. 2025 Jul 1;26(7):e877-e888. doi: 10.1097/PCC.0000000000003757. Epub 2025 May 1.

Helpful Links

• Website for SHIPSS investigation

Study record dates

Study Major Dates

• Study Start (Actual): March 11, 2019
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: January 5, 2018
• First Submitted That Met QC Criteria: January 15, 2018
• First Posted (Actual): January 17, 2018

Study Record Updates

• Last Update Posted (Estimated): October 30, 2025
• Last Update Submitted That Met QC Criteria: October 28, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: sepsis; mortality; health-related quality of life; hydrocortisone; refractory septic shock; new/progressive MODS; corticosteroid adverse events; sepsis biomarkers
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Shock; Pathological Conditions, Signs and Symptoms; Sepsis; Shock, Septic; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Pharmaceutical Preparations; Polycyclic Compounds; Pregnanes; Steroids; Fused-Ring Compounds; Crystalloid Solutions; Isotonic Solutions; Solutions; Pregnenediones; Pregnenes; 11-Hydroxycorticosteroids; Hydroxycorticosteroids; Adrenal Cortex Hormones; 17-Hydroxycorticosteroids; Hydrocortisone; Saline Solution
• Other Study ID Numbers: IRB-P00027662; 1R01HD096901-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Per NIH policy, the SHIPSS investigators will provide a de-identified dataset and all the data-related documentation necessary to utilize the study data (dictionary, calculated variables, and standard operating procedures) to the NIH no later than 3 years after the final 90-day assessment or 2 years after the primary paper has been published, whichever comes first. The investigators will submit this dataset to the NICHD data repository, Data and Specimen Hub (DASH). In addition, final datasets and statistical analyses will be archived.
• IPD Sharing Time Frame: No later than 3 years after the final 90-day assessment or 2 years after the primary paper has been published, whichever comes first.
• IPD Sharing Access Criteria: Anyone can access NICHD DASH, which is a public website with free access to the scientific research community. All users may browse and view information about studies and data archived in NICHD DASH. Users who are interested in submitting or requesting study data must register for a free account.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No