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Concurrent Session 3: Clinical Trials

Tracks
Track 1
Friday, September 8, 2023
2:15 PM - 3:45 PM
Grand Canal

Speaker

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Dr Anna Curley
National Maternity Hospital

Learnings from Planet 2

2:15 PM - 2:45 PM

Biography

Dr Anna Curley works in the National Maternity Hospital, Dublin She was previously a neonatal consultant in Cambridge, UK for 11 years and has worked in Ireland, UK, Australia and Africa. She is an Associate Professor in University College Dublin. Whilst working as a neonatologist in Cambridge, Anna also worked in medical regulation for the Medical Council from 2013-2016. Her original research doctorate was based on chronic lung disease in preterm infants and her subspecialty clinical interest is in Neonatal Cardiorespiratory medicine. She has been involved in multiple neonatal randomised controlled trials as Chief Investigator or co-investigator. She was co-chief investigator of PlaNeT-2 study, a platelet transfusion threshold trial which demonstrated increased mortality/major bleeding with the use of higher neonatal platelet transfusion thresholds and is now preparing the PlaNeT-3 study of differing platelet volumes in preterm babies funded by the HRB.
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Dr Bethou Adhisivam
Professor
Jawaharlal Institute of Postgraduate Medical Education & Research

Does early fortification of human milk decrease time to regain birth weight as compared to late fortification among preterm infants? - A Randomized Controlled Trial

2:45 PM - 2:55 PM

Abstract

Background: Early fortification of human milk can be useful for optimizing nutrition for preterm Very low birth weight (VLBW) infants and help in better growth and subsequent neurodevelopment . However, there are concerns of feed intolerance and NEC.
Objective: To compare the duration required to regain birth weight following early fortification of human milk versus late fortification among preterm infants.
Methods: This randomized controlled trial included hemodynamically stable 120 preterm infants (≤32 weeks of gestation). The intervention and comparator groups received standard fortification with human milk fortifier when enteral feeds reached 30 ml/kg/day (early fortification) and 80 ml/kg/day (late fortification) respectively. Neonates in both the groups received feed increments as per standard NICU protocol. Anthropometric measurements (weight, length, and head circumference) at birth and during postnatal follow-up were done following standard precautions and plotted on the sex-specific Fenton growth charts.
Results: Preterm neonates who received early fortification regained birth weight earlier compared to those in the late fortification group (10.13 ± 2.90 Vs 11.26 ± 3.06, p < 0.05). The weight gain velocity, linear growth and increase in head circumference were better in the early fortification group. There was no increased risk of culture-positive sepsis, feed intolerance and necrotizing enterocolitis in the early fortification group compared to late fortification.
Conclusions
Standard fortification with human milk fortifier when enteral feeds reach 30 ml/kg/day helps preterm neonates regain birth weight earlier. Early fortification is well tolerated and safe for the population studied.

Biography

Dr Caitriona Ni Chathasaigh
National Maternity Hospital

A Before And After Study Of A Novel Respiratory Function Monitor Designed To Teach Newborn Face Mask Ventilation

2:55 PM - 3:05 PM

Abstract

Background
Respiratory Function Monitors (RFM’s) are used to provide feedback on mask leak, tidal volume and respiratory rate during facemask ventilation but can be difficult to interpret. Previous studies have focused on using RFM’s to identify mask leak without developing training strategies to improve technique.

Objectives
To assess if a standardised facemask ventilation training intervention using an RFM (Monivent NeoTraining, Göteborg, Sweden) designed specifically for use as a training tool, resulted in a reduction in mean facemask leak after training.

Methods
We developed a training intervention incorporating a novel RFM with a simple visual interface, specifically designed for use in neonatal resuscitation training. Healthcare professionals working or training in a hospital providing maternity services were eligible for participation. All participants underwent a standardised training intervention [Figure 1.] using a modified, leak free manikin and RFM comprising; a demonstration on optimal facemask ventilation technique and RFM interpretation followed by a period of deliberate practice. Each participant performed 30 seconds of uninterrupted positive pressure ventilation blinded to the RFM display before and after training. The primary outcome was mean facemask leak after training.

Results
We enrolled 400 participants from 13 hospitals in Ireland. The pre training mean (SD) leak was 40% (30) compared with 16% (14) post training, p = <0.00001. Differences were noted across all other ventilation variables.

Conclusion
Standardised facemask ventilation training using a novel RFM designed for use as a training tool, led to a significant reduction in mean facemask leak and other important respiratory parameters.

Biography

Dr Emma Dunne
Specialist Registrar
National Maternity Hospital

Thermal care for very preterm infants after birth

3:05 PM - 3:15 PM

Abstract

Introduction
Hypothermia after birth is an independent risk factor for mortality in very preterm infants. Delayed cord clamping (DCC) after birth is now a mainstay of management for preterm infants. Relatively little is known about temperature control in preterm infants in the era of DCC, and in the hours following admission to the neonatal intensive care unit (NICU).

Objective
To improve the understanding of thermoregulation during this time.

Methods
We performed a number of prospective studies, including two randomised controlled trials (CTRN: NCT04463511,NCT04761484), in very preterm infants between July 2020 – December 2022.

Results
The majority of neonatal units in Ireland perform DCC for 60 seconds after birth, however none routinely provide thermal care before the cord is clamped. Since the introduction of DCC, the time to initiate warming interventions is greater than the 60 seconds recommended by international guidelines, and admission hypothermia has increased (6% -> 54%). Placing infants in polyethylene bag before cord clamping, compared to after, does not result in more infants with a normal admission temperature. A large proportion (83%) of infants are hypothermic in the 2 hours following admission. Placing a peripheral intravenous catheter instead of an umbilical catheter, does not increase the number of infants with a normal temperature 2 hours after birth. Infants are at risk of heat loss after the incubator canopy is lowered.

Conclusion
Preterm infants are at risk of heat loss during DCC, and following admission to the NICU. Further studies are needed to inform future guidelines for thermal care.

Biography

Dr Lucy Geraghty
National Maternity Hospital

A Randomised, Crossover Study of Standard Laryngoscope and Two Videolaryngoscopes (Acutronic Infant View & C-Mac) for Endotracheal Intubation of Newborn Mannequins

3:15 PM - 3:25 PM

Abstract

Aim:
To compare direct laryngoscopy with a standard laryngoscope (SL) to indirect laryngoscopy with 2 videolaryngoscopes (VLs) for endotracheal intubation of newborn mannequins.

Design:
Randomised crossover study.

Setting:
University maternity hospital in Dublin, Ireland.

Subjects:
Twenty-five clinicians; 6 senior doctors, 18 trainee doctors and 1 advanced neonatal nurse practitioner.

Interventions:
Each participant used a SL and two VLs – Acutronic InfantView and C-MAC – to intubate a preterm and a term newborn mannequin in randomly assigned order.

Main Outcome Measures:
Success at first attempt, duration of successful attempts, participant preferences for devices.
Results:
Overall, first attempt success rates were SL 84% versus Acutronic 76% versus C-MAC 94% and the median (IQR) duration of successful attempts were similar with each device. In the preterm mannequin, the success rates and median duration of successful attempts were comparable for all devices. In the term mannequin, the success rate was lower and the median duration of successful attempt was longer when participants used the Acutronic VL. Most participants preferred the C–MAC.

Conclusion:
Participants were similarly proficient at intubating newborn mannequins when performing direct laryngoscopy with a SL or indirect laryngoscopy with C-MAC. Direct and indirect laryngoscopy merit comparison in a randomised trial in newborns.

Biography

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Dr Sunil Kumar Mehendiratta
Head Of Department, Senior Consultant
Venkateshwar Hospital

Impact of Telephonic Counselling on Exclusive Breastfeeding at 6 Months in Postnatal Mothers During Covid 19 Pandemic. A Randomized Clinical Trial

3:25 PM - 3:35 PM

Abstract

Aim
This study aimed to investigate the impact of telephonic counselling on mothers delivered in hospital during the COVID‐19 pandemic period for exclusive breastfeeding till 6 months postnatal.
Background
During Covid 19 Pandemic there was fear of visiting the hospital and physical counselling was not possible, hence telephonic counselling was done to sustain breastfeeding.

Method
A prospective randomized controlled trial study was conducted with 234 recently delivered mothers (116 in the experimental group and 118 in the control group) between September 2020 and April 2022. Data and was collected using pre-designed proforma and questioner, during hospital stay in both groups. Both groups received routine lactation counselling as per our hospital protocol during hospital stay. In addition, experimental group received 6 telephonic lactation counselling sessions by trained counsellor at 2,4,8,12,16,20 weeks of age of newborn.
At 6 months age of newborn, data was again collected from mothers from both groups. Mothers were compared after 6 months for exclusive breastfeeding
Results
It was observed that 104/116 (89.65%) mothers were doing exclusive breastfeeding in experimental group as compared to 77/118 (65.25%) in control group (P value < 0.00001).
Conclusions
Study revealed that telephonic consultation was effective in improving the exclusive breastfeeding during Covid 19 pandemic when physical counselling was not possible due to fear and restrictions. Continuous support to mothers during breastfeeding gives a positive impact on exclusive breastfeeding.

Biography


Chair

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Anup Katheria
Sharp Mary Birch Hospital for Women & Newborns

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Christian Poets
University Hospital, Tuebingen

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