deltatrials
Terminated NA INTERVENTIONAL 2-arm NCT03521310

Immediate Parent -Infant Skin-to-Skin Study (IPISTOSS)

Sponsor: Björn Westrup, MD PhD

Conditions Prematurity
Updated 7 times since 2018 Last updated: Dec 16, 2021 Started: Apr 1, 2018 Primary completion: Oct 12, 2021 Completion: Oct 12, 2021
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Terminated

Continued randomization was questioned on ethical grounds after the WHO iKMC study reported mortality reduction in May 2021. The DSMB recommended to stop the trial after reviewing a preliminary data analysis because of benefit of the intervention.

This NA trial investigates Prematurity and is currently terminated or withdrawn. Björn Westrup, MD PhD leads this study, which shows 7 recorded versions since 2018 — indicating limited longitudinal coverage. The change history captured here reflects the iterative nature of clinical trial conduct.

Status Flow

~Jun 2018 – ~Sep 2018 · 3 months · monthly snapshotNot Yet Recruiting~Sep 2018 – ~Jul 2020 · 22 months · monthly snapshotRecruiting~Jul 2020 – ~Jan 2021 · 6 months · monthly snapshotRecruiting~Jan 2021 – ~Feb 2022 · 13 months · monthly snapshotRecruiting~Feb 2022 – ~Jul 2024 · 29 months · monthly snapshotTerminated~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotTerminated~Sep 2024 – present · 24 months · monthly snapshotTerminated

Change History

7 versions recorded
  1. Sep 2024 — Present [monthly]

    Terminated NA

  2. Jul 2024 — Sep 2024 [monthly]

    Terminated NA

  3. Feb 2022 — Jul 2024 [monthly]

    Terminated NA

    Status: RecruitingTerminated

  4. Jan 2021 — Feb 2022 [monthly]

    Recruiting NA

  5. Jul 2020 — Jan 2021 [monthly]

    Recruiting NA

Show 2 earlier versions
  1. Sep 2018 — Jul 2020 [monthly]

    Recruiting NA

    Status: Not Yet RecruitingRecruiting

  2. Jun 2018 — Sep 2018 [monthly]

    Not Yet Recruiting NA

    First recorded

Apr 2018

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Björn Westrup, MD PhD
  • University of Bergen
Data source: Karolinska Institutet

For direct contact, visit the study record on ClinicalTrials.gov .