Circulatory Failure in Newborn Infants Clinical Trial
Official title:
NeoAdapt 1: A Study of Circulatory Adaptation of Newborn Infants After Birth
The current definitions of neonatal shock/circulatory failure are outdated and inaccurate.
This makes the development of evidence based protocols for its treatment very difficult.
Furthermore these definitions often rely on invasive methods of monitoring in patients such
as an arterial line. Since the advent of functional echocardiography in neonatology there
has been increased interest in non-invasive measurements of neonatal circulatory failure.
However research in this field has been confined to premature infants.
The purpose of the this research is to look at non invasive methods of assessing an infants
circulatory status in infants older than 33 weeks gestational age in order to fill the
knowledge gap here and help in the development a new definition of neonatal circulatory
failure.
Research has shown that the current definitions used by doctors to assess and treat infants
who have a circulatory problem are inaccurate and lead to a large differences in how doctors
treat this problem in babies. Treatments for circulatory problems in babies can involve the
giving of medication such as adrenaline, dobutamine or dopamine. However these drugs are not
licensed for use in babies and have potentially harmful side effects.
By investigating new methods of assessing a babies circulatory status we intend to help
create a new definition of circulatory failure which will in turn help doctors create
further studies to identify infants with circulatory failure and find the best ways of
treating this condition in babies. So far research in this area has been confined to babies
born at less than 33 weeks gestation. We intend to extend the knowledge in this area to
infants older that 33 weeks gestation.
This is a pilot prospective observational study in babies older that 33 weeks. Infants will
been considered to be from a healthy population (i.e. receiving routine care on the
postnatal care or special care on the neonatal unit). Potential participants will be
approached by a member of the research team and given information about the study and
informed consent will be taken.
For the first three days of their lives all included infants will have two specific
measurements once a day. These are known as:-
1. Superior vena cava flow assessment- This involves measuring the blood flow through one
of large veins that is connected to the babies' heart using an ultrasound machine. It
is a painless procedure that is well tolerated by infants.
2. Pleth variability index- This involves placing a small probe on the baby's hand or foot
that will measure their oxygen levels. This will be done at the same time as the
superior vena cava flow assessment is performed. Again this is a painless procedure
that is well tolerated by infants.
Prior to these measurements the infants will have there blood pressure, heart rate, oxygen
saturation's and capillary refill time assessed.
This assessments will be performed in addition to the routine care they receive. Infants
will therefore have these measurements performed three times for the purpose of the study.
If an infant is discharged by the clinical team before the third day of life then the
measurements that have been performed prior to discharge will be included in the final
analysis.
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Observational Model: Cohort, Time Perspective: Prospective