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The effect of clustered care on physiological and behavioral responses in preterm infants

The effect of clustered care on physiological and behavioral responses in preterm infants: Randomised cross-over clinical trial

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
IRCT
Registry ID
IRCT201302058315N5
Enrollment
Unknown
Registered
2013-05-13
Start date
2013-05-15
Completion date
Unknown
Last updated
2018-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Other preterm infants. 28 completed weeks or more but less than 37 completed weeks (196 completed days but less than 259 completed days) of gestation.

Interventions

Intervention 1: Clustered care including four invasive procedures (stressor score ten) consists of measuring axillary temperature (2 points), change location of pulse oximeter probe (2 points), gavage
Clustered care including four invasive procedures (stressor score ten) consists of measuring axillary temperature (2 points), change location of pulse oximeter probe (2 points), gavage (3 points) and
Clustered care including three invasive procedures (stressor score seven) consists of measuring axillary temperature (2 points), change location of pulse oximeter probe (2 points) and changing positio
Clustered care including five invasive procedures (stressor score thirteen) consists of measuring axillary temperature (2 points), change location of pulse oximeter probe (2 points), weighing (3 point

Sponsors

Vice chancellor for research, Tabriz University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
30 Years to 32 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: Being admitted to the NICU; infants' age between 30-32 weeks at birth and 32 weeks during the study; having a minimum weight of 1000 g at the time of study; consent form is signed by parents; absence of congenital anomalies; written order of a physician for gavage; without prohibited changing position; respiratory score lower than or equal to five; no status of asphyxia Exclusion criteria: Infants with IVH grade 3 and 4; periventricular leukomalacia; need for mechanical ventilation; steady decline in HR and O2 sat and respiratory rate of normal range; septicemia or be transferred to the neonatal unit refrain from further testing.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Behavioral responses. Timepoint: Two minutes before the start of clustered care, during the clustered care and by two minutes after it. Method of measurement: The camera is already installed.;Physiological responses. Timepoint: Two minutes before the start of clustered care, during clustered care and by two minutes after it. Method of measurement: The camera is already installed.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMarziyeh Avazeh

Tabriz School of Nursing and Midwifery

m.avazeh@yahoo.com00984262232793, 00989141284596

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026