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Research in the NICU

We have many research studies involving babies and parents on the Neonatal Unit.

During your baby’s stay, you may be asked if you would like to take part in a research study. If this happens, we will find an appropriate time to give you more information about the study.

You will always be given space to consider whether you would like your baby to take part. If you would like to know more about any particular study, please ask to be put in contact with one of the research team.

To contact the NICU research team, email us at cuh.nicu.research@nhs.net

ANIMATE fUSiON

Wearable neuroimaging technologies to study infant motor development

Principal Investigator: Dr Topun Austin: topun.austin1@nhs.net

IRAS: 241042 CPMS: 37703

Aim: to develop a new, wearable, infant-friendly optical brain imaging technology to study the development of the motor system in both healthy and at-risk infants. The ultimate goal is to demonstrate that this technology can provide a new, objective approach to the identification and monitoring of infants with cerebral palsy.

The early diagnosis of cerebral palsy is critical. While there is no cure for the condition, there are a number of treatments that can improve an infant's long-term motor ability. During the first few weeks and months of life the brain is highly adaptable, which means it is likely to be at its most susceptible to treatment. If infants with abnormal motor development could be identified early, these treatments would have the greatest chance of success

Contact:

Documents:

COMET

Cooling in mild encephalopathy.

Principle Investigator: Dr Mallika Pinnamaneni ragamallika.pinnamaneni@nhs.net

IRAS: 326176 CPMS: 41335

AIM: Does whole-body hypothermia to 33.5 ±0.5°C, initiated within 6 hours of birth and continued for 72 hours, improve cognitive
development at two years of age after mild hypoxic ischemic encephalopathy (HIE) compared with targeted normothermia at 37.0 ±0.5°C?

Inclusion criteria:

  • Evidence of intra-partum hypoxia-ischemia defined as any of – (i) Apgar score of <5 at 10 minutes after birth, or continued need for resuscitation at 10 minutes after birth or severe birth acidosis defined as any occurrence of: pH <7.00 or Base deficit >16mmol/l in any cord or baby gas sample within 60 minutes of birth
  • Evidence of mild hypoxic ischaemic encephalopathy defined as – two or more abnormal findings in any of the six categories of the modified Sarnat examination (level of consciousness, spontaneous activity, posture, tone, primitive reflexes, and autonomic nervous system) but not meeting the diagnosis of moderate or severe hypoxic ischaemic encephalopathy on a standardised examination performed by a certified examiner between 1 to 6 hours of age
  • Normal amplitude on aEEG performed for at least 30 minutes between 1 to 6 hours of age. Normal amplitude will be defined as upper margin of the aEEG activity more than 10 microvolts and the lower margin more than 5 microvolts on a single channel aEEG
  • Written informed consent, telephone consent may be obtained

Exclusion criteria:

  • Infants who meet the BAPM criteria for whole-body hypothermia
  • Infants without encephalopathy defined as less than two abnormalities on structured neurological examination.
  • Infants with major congenital or chromosomal anomalies identified prior to randomisation.
  • Infants with birthweight <1800g.
  • Infants who received muscle relaxation, or anti-seizure medications prior to neurological assessment.
  • Infants with moderate or severe background voltage abnormalities or seizures on amplitude integrated electroencephalography (aEEG)
  • Infants already enrolled in interventional studies

Contact:

Resources:

COMET - Cooling in Mild Encephalopathy trial (opens in a new tab)

DOLFIN

Developmental Outcomes of Long-term Feed Supplementation in Neonates.

Principal Investigator: Dr Kathy Beardsall kb274@medschl.cam.ac.uk

IRAS: 303421   CPMS:

Aim: multicentre, blinded, randomised controlled trial to investigate whether giving a nutritional supplement daily for a year improves long-term cognitive development in babies who are born very early or who suffer poor blood supply or lack of oxygen to the brain before or around birth.

Nutrients docosahexaenoic acid (DHA) - a long chain polyunsaturated fatty acid (LCPUFA), choline and Uridine-5-monophosphate (UMP) are particularly important for brain development and may improve neurodevelopmental outcomes. The Dolphin neonatal study ran from 2009 to 2013 in 3 UK Neonatal Units. Results showed that the treatment group had higher mean cognitive scale scores and language scale scores on the Bayley Scales of Infant Development III compared to the placebo control group, indicating that a larger trial was warranted. In response to this and an NIHR commissioned call, the DOLFIN trial was set up.

The DOLFIN trial aims to evaluate whether nutritional supplementation with a nutrient blend containing long-chain polyunsaturated fatty acids (LCPUFAs), choline, uridine-5'-Monophosphate (UMP), and cytidine-5'- monophosphate (CMP) plus usual care from birth to 12 months post estimated date of delivery (EDD) improves cognitive development at 24 months post EDD, compared to infants receiving a matched placebo supplement plus usual care (comparator).

Babies will be in one of two groups:

  • Active supplement: Micronutrient breast milk/formula milk/food supplement containing LCPUFAs, choline, UMP, and CMP

or

  • Matched placebo control supplement

Inclusion criteria:

  • Babies born less than 28 weeks of gestation (preterm group)
  • Babies born at 35 weeks of gestation or more, receiving therapeutic hypothermia for hypoxic ischaemic encephalopathy (HIE group)
  • Written informed parental consent

Exclusion criteria:

  • Middle Cerebral Artery infarcts
  • Major congenital brain malformation, or genetic condition with abnormal brain development
  • Infants with galactosaemia
  • Infants receiving jejunal feeds

Documents:

Contact:

Resources:

ELGAN

A Multi-center, double-blind, randomised, 2-arm, parallel-group, placebo controlled study to assess the efficacy and safety of ELGN-2112 on intestinal malabsorption in preterm infants.

Principle Investigator: Dr Catriona Macdougall: catriona.macdougal@nhs.net
IRAS: 1007828 CPMS: 57067

The study will evaluate the efficacy and safety of ELGN-2112 on intestinal malabsorption in preterm infants as compared to placebo. ELGN-2112 is a powder for reconstitution containing human recombinant insulin, reconstituted in breast milk, infant formula, water, or normal and half normal saline, and administered concomitantly with preterm infant's enteral nutrition for local gastrointestinal therapy.

Inclusion criteria:

  • Corrected gestation <32 weeks
  • Birth weight >500 grams
  • Fractional oxygen requirement <0.6 at enrolment
  • Tolerate feeds and expected to wean of TPN whilst in CUH NICU
  • Written informed consent

Exclusion criteria:

  • Baby is on >100 mls/kg/day enterally at study entry
  • Not receiving lipid TPN
  • IUGR less than 3rd percentile
  • Confirmed NEC
  • Maternal diabetes where insulin was required
  • Suspected or confirmed hyperinsulinemia requiring glucose administration of more than 12 mg/kg/min at randomisation
  • Any systemic insulin administration at randomisation
  • Heart and chest compression or any resuscitation drugs given to the infant during delivery
  • At risk for significant GI complications such as twin-to-twin transfusion syndrome (TTTS) or monochorionic monoamniotic twins
  • Participation in another interventional clinical study that may interfere with the results of this trial
  • Hypersensitivity to any of the drug components- Recombinant Human Insulin (rh-Insulin), Maltodextrin, Sodium Chloride

Contact:

FOOTPRINTS

Randomised controlled trial of IGF-1 in preventing chronic lung disease compared to standard neonatal care in extremely premature infants.

Principle Investigator: Dr Kathy Beardsall kathryn.beardsall2@nhs.net

IRAS: 258672 CPMS: 41335

Aim: This study will assess the safety and effectiveness of the drug SHP607-202, in preventing chronic lung disease (CLD) compared to standard neonatal care in extremely premature infants.

Babies born extremely prematurely have a higher risk of chronic lung disease (CLD) and other complications, which may result from low levels of certain hormones called growth factors. These complications may include a lung disorder called bronchopulmonary dysplasia (BPD), as well as other disorders such as bleeding in the brain (called intraventricular haemorrhage or IVH) and vision complications that can affect eyesight called retinopathy of prematurity (ROP).

Extremely preterm infants have low Insulin-like Growth Factor 1 (IGF-1) levels, and this is a risk factor for CLD and other complications of extreme prematurity. By increasing serum IGF-1 levels via OHB607 (study drug) administration, we may reduce the incidence of CLD and other complications of extreme prematurity.

Contact:

MeCool

Metabolic Monitoring During Therapeutic Hypothermia for Hypoxic Ischaemic Encephalopathy.

Principal Investigator: Dr Kathryn Beardsall kb274@medschl.cam.ac.uk

IRAS: 251956  

Feasibility study of the use of real time CGM in babies undergoing therapeutic hypothermia for hypoxic ischaemic encephalopathy.

In the UK approximately 1200 babies per year undergo therapeutic hypothermia for hypoxic ischaemic encephalopathy (HIE). HIE not only impacts on brain metabolism but disturbs the normal metabolic balance in these babies who are at risk of hypoglycaemia and hyperglycaemia, which may exacerbate the effect of their primary brain injury. The clinical significance of hypoglycaemia is dependent on the availability of alternative fuels such as ketones and lactate. Clinical management of glucose control in these extremely ill babies is challenging because of infrequent blood glucose measurements and inability to measure alternative fuels. We have used continuous glucose monitoring (CGM) to help target glucose control in extremely preterm infants who require intensive care. CGM however has not been used in babies who are being cooled. This study aims to determine if CGM can be safely used in these babies, and to use this alongside innovative methods to measure alternative fuels to optimise care of these vulnerable babies.

Aim: To carry out preliminary evaluation of feasibility of real time continuous glucose monitoring alongside metabolic monitoring in a cohort of infants requiring cooling for HIE.

Data will be blinded to clinical staff and parents. The CGM is still collecting data but it cannot be seen. The screen will show 'Display Off'.

Calibrations need to be done 12 hourly

Inclusion criteria:

  • Infants undergoing therapeutic cooling for hypoxic ischaemic encephalopathy
  • Written informed consent from parent or guardian

Documents:

Contact:

Meerkat

Monitoring key activity and physiology of neonates in intensive care.

Principal Investigator: Dr Kathryn Beardsall kb274@medschl.cam.ac.uk

IRAS: 285615

Aim: To develop and evaluate a camera-based physiological monitoring system for non-contact monitoring of vital signs and activity. This study will compare the accuracy of non-contact monitoring against standard monitoring in the newborn age group.  

The NICU attends to the needs of critically ill new-born babies, including many who are born prematurely. Specialist clinical care is combined with each baby's individual development needs, as well as supporting parents to bond with their new baby.

Patient monitoring in NICU typically uses wired sensors attached by sticky pads, or fabric cuffs. These devices can cause irritation to the skin, and the wires can create a barrier for parents. A non-contact monitoring system removes this risk, reduces infection risk as the device is outside of the incubator and infant activity can be monitored without contact.

The Meerkat non-contact monitoring system uses a camera that is secured above the cot or incubator and records 3D images. The images are transmitted to a laptop for activity and vital sign analysis. Noise volume and frequency data is also being collected. Voice and audio is not being recorded. Further information available on the Meerkat Nursing Information sheet. 

The study is in two parts:

Phase 1: Pose detection training - completed December 2021

Phase 2: Validating the non-contact monitoring system - currently recruiting

  • 24 hours of data collection, all clincal and nursing care to carry on as normal, the study will make no changes will be made to the baby's position, clothing or other care provision

Inclusion criteria:

  • Babies in the neonatal intensive care unit
  • Written informed consent from parent or guardian

Supporting information

A video demonstrating set up of the Meerkat system and disconnection of the camera when the incubator lid needs to be raised has been created and can be viewed on the link below

Meerkat set up video (opens in a new tab)

Documents:

Contact:

NEWTS

Neonatal Wireless Transmission System.

Principal Investigator: Dr Kathryn Beardsall

The neonatal intensive care unit (NICU) in a hospital attends to the needs of critically ill newborn babies, some of whom are born prematurely. The care provided is among the most intensive, specialised and high dependency within the hospital environment. Uniquely, the unit combines this clinical care with attending to each baby's individual developmental needs, as well as supporting the parents as they bond with their child.

The babies typically have several clinical attachments including respiratory support, blood infusion lines, and vital sign monitoring sensors. The vital sign sensors used in this environment include ECG probes (heart activity), thermistors (skin temperature), and pulse oximeters (blood oxygen saturation, SpO2). These sensors are all connected by wires to a monitoring unit outside the incubator.

As part of the exploratory phase of this project, we conducted an interview study at Addenbrooke's Hospital with parents and nurses to investigate their views of the current vital sign monitoring system, and how they would view a wireless system [1]. This study has informed the development of a low power, small footprint wireless transmission unit to allow removal of the wires which tether the baby to the patient monitor.

One of the most important anticipated benefits of a wireless system will be to allow parents to take their babies out of the incubator more easily for skin-to-skin contact. This contact (also known as kangaroo care) has been widely demonstrated to improve clinical outcomes, particularly in pre-term neonates. By making it easier for parents to take their baby out more easily, we hope to increase the amount of skin-to-skin contact that is possible.

Reference: Bonner O, Beardsall K, Crilly N, et al. 'There were more wires than him': the potential for wireless patient monitoring in neonatal intensive care. BMJ Innovations 2017;3:12-18.

TRIPP

Translational Research in Intestinal Physiology and Pathology.

Principal Investigator: Dr Matthias Zilbauer mz304@medschl.cam.ac.uk

IRAS: 222907 CPMS: 34481

Aim: The Department of Paediatric Gastroenterology at Addenbrooke's Hospital is actively involved in research into diseases of the bowel in children. The diseases include inflammatory bowel disease (Crohn's disease and ulcerative colitis), Necrotising Enterocolitis (NEC), coeliac disease, food allergy, gut infection, reflux disease and rare conditions of the gastrointestinal tract.

The TRIPP study is investigating why diseases in the gut occur and develop better strategies to manage children affected by these conditions. TRIPP will be comparing tissue samples obtained from children diagnosed with a gut disease, for example Necrotising Enterocolitis (NEC), with the function of cells obtained from children without the condition.

Any neonate undergoing abdominal surgery may be invited to participate in this study. For patients under 1-year-old (i.e neonates and infants), whose parents have consented to the study prior to surgery, samples for research will be taken from excess tissue, not required for routine diagnostic purposes to be determined by the operating surgeon.

Inclusion criteria:

  • Any neonate undergoing abdominal surgery at Addenbrookes, Cambridge University Hospital Foundation Trust (CUHFT)
  • Written informed consent from parent or guardian

Documents:

Contact:

  • Claire Glemas, Paediatric Research Nurse claire.glemas@nhs.net
  • Kelly Spike, Paediatric Research Nurse kelly.spike@nhs.net
  • Dr  Matthias Zilbauer, Honorary Consultant Paediatric Gastroenterologist 
  • Dr Robert Heuschkel, Consultant Paediatric Gastroenterologist  

This document was correct at the time of printing - 29-05-2025 07:51