NCT03990116

Brief Summary

The objetive of the study is to evaluate the non-inferiority or the equivalence of the kangaroo care position, in lateral versus traditional one in prone measuring the stability of several parameters in premature infants less than 28 weeks of gestational age during the first 5 days of life.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 10, 2019

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

May 23, 2019

Completed
26 days until next milestone

First Posted

Study publicly available on registry

June 18, 2019

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 15, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 15, 2021

Completed
Last Updated

September 26, 2025

Status Verified

September 1, 2025

Enrollment Period

2.5 years

First QC Date

May 23, 2019

Last Update Submit

September 23, 2025

Conditions

Kangaroo CarePremature InfantBody Temperature

Keywords

Patient PositioningKangaroo-Mother Care Methodskin to skinExtremely Premature infant

Outcome Measures

Primary Outcomes (1)

  • Change from skin temperature

    Change from skin temperature after kangaroo care Peripheral temperature of the premature measured in the axilla with Braun® PRT2000 thermometer and the continuous temperature monitoring sensor of Giraffe ® incubators (AirLife TM infant skin temperature probe)

    T0: baseline; T1: 30 minutes after to start kangaroo care; T2: 30 minutes after to finish kangaroo care

Study Arms (2)

Lateral kangaroo

EXPERIMENTAL

Placing the infant in lateral on the parents chest, keeping the head neutral and limbs flexed towards body midline

Procedure: Lateral

Prone Kangaroo

ACTIVE COMPARATOR

placing the baby in upright and ventral position between mother's breasts or over the father chest, in skin-to skin contact with no clothes in between and with lower limbs flexed

Procedure: Prone

Interventions

LateralPROCEDURE

Posture lateral kangaroo care

Lateral kangaroo
PronePROCEDURE

Posture prone kangaroo care

Prone Kangaroo

Eligibility Criteria

Age1 Minute - 5 Days
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Premature under 28 weeks of gestational age with mother / father who wants kangaroo care.

You may not qualify if:

  • Premature infants with mechanical ventilation in high frequency mode,
  • Premature infants in the immediate postoperative period of major surgery,
  • Premature infants with malformations of the abdominal Wall
  • Premature infants who require immobilization
  • Premature infants who do not tolerate kangaroo care: hemodynamic, thermal instability or increased stress
  • Premature infants with duration of kangaroo care of less than 60 minutes.
  • Also excluded are those patients where the kangaroo care provider has an anatomical limitation for carrying out kangaroo care.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Laura Collados Gómez

Madrid, Madrid, 28030, Spain

Location

Related Publications (1)

  • Collados-Gomez L, Esteban-Gonzalo L, Lopez-Lopez C, Jimenez-Fernandez L, Piris-Borregas S, Garcia-Garcia E, Fernandez-Gonzalo JC, Martinez-Miguel E. Lateral Kangaroo Care in Hemodynamic Stability of Extremely Preterm Infants: Protocol Study for a Non-Inferiority Randomized Controlled Trial CANGULAT. Int J Environ Res Public Health. 2021 Dec 28;19(1):293. doi: 10.3390/ijerph19010293.

    PMID: 35010554DERIVED

MeSH Terms

Conditions

Premature Birth

Interventions

Prone Position

Condition Hierarchy (Ancestors)

Obstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Intervention Hierarchy (Ancestors)

PostureMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Laura Collados, phD

    Hospital Universitario 12 de Octubre

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Nurse at Neonatology Service

Study Record Dates

First Submitted

May 23, 2019

First Posted

June 18, 2019

Study Start

May 10, 2019

Primary Completion

November 15, 2021

Study Completion

November 15, 2021

Last Updated

September 26, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)