None listed
Conditions
Brief summary
Neonatal hypoglycaemia is important because it is linked with poor neurological outcome. In recent years, there has been considerable interest in the detection and management of neonatal hypoglycaemia. Babies who are identified as being at risk are screened using heel-lance blood tests for the first days after birth. If hypoglycaemia is diagnosed, then treatment is usually provided. Glucose is the primary cerebral fuel and the aim of treatment is to increase the blood glucose concentration to ensure adequate cerebral energy supply. The definition of neonatal hypoglycaemia has caused considerable controversy. The current accepted definition < 2.6mM has been determined using limited, but the only available data. However, the normal glucose profile of healthy appropriately grown term newborns has never been reliably described, and it is possible that many babies are being unnecessarily treated. Babies have been shown to use alternative cerebral fuels, primarily lactate and ketones. The profiles of blood lactate and ketone blood concentrations in healthy newborns within the first week are also unclear. We propose a prospective observational cohort study in healthy appropriately grown term newborns to describe the normal glucose, lactate and ketone concentration profiles over the first five postnatal days. Babies enrolled in the study will be cared for as normal newborns, largely by the parents as they progress from hospital, or birthing centre and home. Parents to capture data about every feed electronically. Analysis of the blood will begin as soon as possible after birth, umbilical cord blood will be sampled for the measurement of glucose, lactate and ketones. During the first 24 hours, each baby will have three heel-lance blood tests for the measurement of glucose, lactate and ketones. The timing of these initial blood tests will mirror the current screening protocol for at-risk babies. Following which, babies will have heel-lances blood tests at 8 to 10 hourly intervals (maximum of 16 blood tests over the 5 day period). The results of the blood tests will not be available until the study is completed. In addition a continuous interstitial glucose monitor will be placed subcutaneously, into the baby’s thigh and remain in place for the five days. If “neonatal hypoglycaemia” as currently defined is shown to be part of normal metabolic transition, it is likely that current clinical management will significantly change.
Interventions
The study period is from immediately after birth until the completion of the first five postnatal days.
Blood glucose, lactate and beta-hydroxybutyrate analysis
The first blood sample will be taken from the umbilical cord immediately after birth. All other sampling will be sampled from the babies’ heel just prior to a feed is being initiated, in order to reduce the pain of heel lance. The heel will be warmed, in order to reduce the pain and to aid blood flow. Less than 1 ml (small drop) of
The study period is from immediately after birth until the completion of the first five postnatal days. Blood glucose, lactate and beta-hydroxybutyrate analysis The first blood sample will be taken from the umbilical cord immediately after birth. All other sampling will be sampled from the babies’ heel just prior to a feed is being initiated, in order to reduce the pain of heel lance. The heel will be warmed, in order to reduce the pain and to aid blood flow. Less than 1 ml (small drop) of blood will be taken. The blood will be analysed for glucose and lactate using glucose oxidase and lactate oxidase on the portable epoc 'Registered Trademark' analyser (Epocal Inc. Ottawa. Canada). Beta-hydroxybutyrate will be analysed using the hand held StatStrip 'Registered Trademark' meter (Nova Biomedical, Waltham, MA, USA), which uses a beta-hydroxybutyrate dehydrogenase reaction for analysis. The results will be blinded to the researcher processing the blood sample and not available to any of the research team until the completion of the study. Experienced neonatal nurses or nurse practitioners will perform the heel lances. Timing of the heel-lance blood samples Day One. (Mirroring routine screening) Immediately after birth a cord blood sample will be taken. Heel-lance blood samples will commence at approximately one hour after birth, in accordance with the blood glucose screening protocol at Waikato Hospital, followed by three more samples, at least three to four hours apart. Days Two to Five. Heel-lance samples will be measured every 8 to 10 hours (a 16 maximum of heel-lances will be performed). It is standard practice for the Newborn Screening Card to be collected on Day 3 after birth. Every attempt will be made to link this heel lance with the study blood sampling. Continuous glucose monitor As soon after birth as possible an Ipro2 continuous glucose monitor (Medtronic, Minimed `Registered Trademark', Northridge, USA) will be inserted subcutaneously into the baby’s thigh using the insertion device and remain in place for five days. The sensor will be secured with a transparent dressing. The Ipro 2 does not prevent any normal activities of daily living. The baby can be bathed with the sensor in place. The sensor and dressing will be removed after five completed days, at time which is convenient to the parents. A Remove ' Registered Trademark' (Smith & Nephew, Inc., St Petersburg, USA) wipe will be used to remove the dressing, in order to decrease the potential discomfort. Following removal of the continuous glucose sensor the skin underneath the sensor will be assessed and cleaned. In the event of the sensor becoming dislodged, we will ask the parents if the sensor can be replaced. If the sensor requires replacement, an addition heel lance blood test will be required 1 to 2 hours after the insertion of the new sensor. Feeding data Parents will be encouraged to enter all feeds (breast or bottle) into a commonly used breastfeeding software application (Feed Baby Pro, Penguin Apps, Version 21.0.5, Victoria. Australia) on a small hand held computer device. At the completion of the five-day study period, data will be exported as a CVS file and stored in a secure database, for later analysis. If the parents wish to have a copy of the feeding data, in order to continue using the application on a personal device, we will email the information. Daily Review At enrolment each family will receive an individualised plan, which will indicate the time frames in which the research staff will be visiting the baby to perform the blood tests and daily review. A member of the research team will be on call for the parents at all times. In the unlikely event of a baby becoming unwell for any reason, the baby will be assessed and referred for treatment. A clinician, who is not part of the study team, will provide treatment. The principal investigator will also be notified. Any required blood samples will be taken as clinical indicated, independent of the study protocol. All babies will remain in the study, unless the parents request otherwise.
Sponsors
Waikato District Health Board
Eligibility
Sex/Gender
All
Age
0 to 6 Days
Healthy volunteers
Yes
Inclusion criteria
Babies who are 1. 37 to 42 weeks’ gestation and assessed as appropriate for gestational age at birth. 2. Appropriate weight for gestational age (birth weight > 10th centime and < 90th centile). 3. Singletons 4. Living within 20 kilometers of Waikato Hospital 5. English-speaking parents
Exclusion criteria
Babies will be excluded who have any of the following 1. Birthweight < 2500g or > 4500 g 2. Apgar score < 7 at five minutes of age 3. Skin conditions preventing the attachment of the continuous glucose monitor 4. Unwell for any reason 5. Major congenital abnormalities or terminal conditions. 6. Born to mothers with an antenatal history of diabetes, hypertension, drug dependency, or using medications, which may affect the newborns blood glucose concentration, e.g. corticosteroids, sodium valproate. 7. Born to mothers with a Body Mass Index < 18.5 or > 30 kg/m2
Outcome results
None listed