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The Essential Newborn Observations and Signs study: Investigating vital sign ranges in well newborns greater than 34 weeks gestation. A prospective observation study

The Essential Newborn Observations and Signs study: Investigating vital sign ranges in well newborns greater than 34 weeks gestation. A prospective observation study

Status
Completed
Phases
Unknown
Study type
Observational
Source
ANZCTR
Registry ID
ACTRN12618000992202
Acronym
The ENOS study
Enrollment
190
Registered
2018-06-13
Start date
2018-10-10
Completion date
2019-10-10
Last updated
2019-10-28

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

Conditions

None listed

Brief summary

This is an observational study looking at well newborn babies’ essential observations such heart rate, breathing (respiratory) rate, blood pressure, temperature and oxygen levels (saturations) to determine the ranges for each of these essential (vital) signs. Very few studies have measured these essential observations for any length of time and many of the ranges have been adapted from paediatric studies or intermittent observations. At the present time, it is unknown whether there are differences in ranges between those babies born late preterm (greater than 34 weeks) compared to those born at term (greater than 37 weeks) or how behaviours such as sleeping, feeding or crying influence these observations as these may contribute to the early signs of deterioration. Understanding if there are differences in these essential observations is important to inform early warning observation tools and the subsequent care that babies may need. This study will be conducted in the postnatal ward and special care nursery at the Royal Brisbane and Women’s Hospital. This study will monitor a baby’s essential observations during normal activities such as cuddling, feeding and sleeping for periods of up to 6 hours each day during hospital stay, in addition to the routine monitoring of essential observations currently undertaken. Findings will potentially inform newborn care practices in Australia and overseas and reduce unnecessary separation of babies from their mothers as a result of the baby being transferred to a nursery for closer monitoring.

Interventions

This study will explore newborn essential observations such heart and breathing rates, blood pressure, temperature and oxygen levels continuously for up to 6 hours per day for the duration of admission. This will be undertaken to determine the ranges and whether there are differences in each gestational age group for each of these essential (vital) signs.

Sponsors

The University of Queensland
Lead SponsorUniversity

Eligibility

Sex/Gender
All
Age
2 Hours to 7 Days
Healthy volunteers
Yes

Inclusion criteria

Inclusion criteria • Male and Female Newborns born greater than or equal to 34 weeks gestation • Born via vaginal delivery or caesarean section • APGAR score greater than or equal to 7 • Well newborn admitted directly to the postnatal ward, or directly to the special care nursery (for routine observations in accordance with hospital policy that all newborns born less than 35 weeks gestational age or less than 2400g birthweight require initial admission to the special care nursery.

Exclusion criteria

Exclusion criteria • Male and Female newborns born less than 34 weeks gestation • Emergency delivery in which the newborn required resuscitative measures at delivery such as assisted ventilation; cardiopulmonary resuscitation; or surfactant administration • Admitted directly to the Neonatal Intensive Care nursery • Has a known congenital disorder (e.g. cardiac, pulmonary) • Has signs of respiratory distress or a previous episode of respiratory distress requiring treatment • Had two or more BGLs of less than 2.6mmol/L • Had two or more temperatures of less than 36.5°C • Phototherapy requiring additional supportive management/treatment in SCN • Born to a mother with a significant medical condition and/or history of recreational drug use during pregnancy. • Retrieved from another healthcare facility • Discharged from the Royal Brisbane and Women’s Hospital then re-admitted

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026