Innovation in immediate neonatal care: development of the Bedside Assessment, Stabilisation and Initial Cardiorespiratory Support (BASICS) trolley

OBJECTIVE: Babies receive oxygen through their umbilical cord while in the uterus and for a few minutes after birth. Currently, if the baby is not breathing well at birth, the cord is cut so as to transfer the newborn to a resuscitation unit. We sought to develop a mobile resuscitation trolley on which newly born babies can be resuscitated while still receiving oxygenated blood and the 'placental transfusion' through the umbilical cord. This would also prevent separation of the mother and baby in the first minutes after birth. DESIGN: Multidisciplinary iterative product development. SETTING: Clinical Engineering Department of a University Teaching Hospital. METHODS: Following an initial design meeting, a series of prototypes were developed. At each stage, the prototype was reviewed by a team of experts in the laboratory and in the hospital delivery suite to determine ease of use and fitness for purpose. A commercial company was identified to collaborate on the trolley's development and secure marking with the Conformite Europeenne mark, allowing the trolley to be introduced into clinical practice. RESULTS: The trolley is a small mobile resuscitation unit based on the concept of an overbed hospital table. It can be manoeuvred to within 50 cm of the mother's pelvis so that the umbilical cord can remain intact during resuscitation, irrespective of whether the baby is born naturally, by instrumental delivery or by caesarean section. Warmth for the newborn comes from a heated mattress and the trolley has the facility to provide suction, oxygen and air. CONCLUSIONS: This is the first mobile resuscitation device designed specifically to facilitate newborn resuscitation at the bedside and with an intact cord. The next step is to assess its safety, its acceptability to clinicians and parents, and to determine whether it allows resuscitation with an intact cord

Improving quality of care and outcome at very preterm birth: the Preterm Birth research programme, including the Cord pilot RCT

BACKGROUND: Being born very premature (i.e. before 32 weeks’ gestation) has an impact on survival and quality of life. Improving care at birth may improve outcomes and parents’ experiences. OBJECTIVES: To improve the quality of care and outcomes following very preterm birth. DESIGN: We used mixed methods, including a James Lind Alliance prioritisation, a systematic review, a framework synthesis, a comparative review, qualitative studies, development of a questionnaire tool and a medical device (a neonatal resuscitation trolley), a survey of practice, a randomised trial and a protocol for a prospective meta-analysis using individual participant data. SETTING: For the prioritisation, this included people affected by preterm birth and health-care practitioners in the UK relevant to preterm birth. The qualitative work on preterm birth and the development of the questionnaire involved parents of infants born at three maternity hospitals in southern England. The medical device was developed at Liverpool Women’s Hospital. The survey of practice involved UK neonatal units. The randomised trial was conducted at eight UK tertiary maternity hospitals. PARTICIPANTS: For prioritisation, 26 organisations and 386 individuals; for the interviews and questionnaire tool, 32 mothers and seven fathers who had a baby born before 32 weeks’ gestation for interviews evaluating the trolley, 30 people who had experienced it being used at the birth of their baby (19 mothers, 10 partners and 1 grandmother) and 20 clinicians who were present when it was being used; for the trial, 261 women expected to have a live birth before 32 weeks’ gestation, and their 276 babies. INTERVENTIONS: Providing neonatal care at very preterm birth beside the mother, and with the umbilical cord intact; timing of cord clamping at very preterm birth. MAIN OUTCOMES MEASURES: Research priorities for preterm birth; feasibility and acceptability of the trolley; feasibility of a randomised trial, death and intraventricular haemorrhage. REVIEW METHODS: Systematic review of Cochrane reviews (umbrella review); framework synthesis of ethics aspects of consent, with conceptual framework to inform selection criteria for empirical and analytical studies. The comparative review included studies using a questionnaire to assess satisfaction with care during childbirth, and provided psychometric information. RESULTS: Our prioritisation identified 104 research topics for preterm birth, with the top 30 ranked. An ethnographic analysis of decision-making during this process suggested ways that it might be improved. Qualitative interviews with parents about their experiences of very preterm birth identified two differences with term births: the importance of the staff appearing calm and of staff taking control. Following a comparative review, this led to the development of a questionnaire to assess parents’ views of care during very preterm birth. A systematic overview summarised evidence for delivery room neonatal care and revealed significant evidence gaps. The framework synthesis explored ethics issues in consent for trials involving sick or preterm infants, concluding that no existing process is ideal and identifying three important gaps. This led to the development of a two-stage consent pathway (oral assent followed by written consent), subsequently evaluated in our randomised trial. Our survey of practice for care at the time of birth showed variation in approaches to cord clamping, and that no hospitals were providing neonatal care with the cord intact. We showed that neonatal care could be provided beside the mother using either the mobile neonatal resuscitation trolley we developed or existing equipment. Qualitative interviews suggested that neonatal care beside the mother is valued by parents and acceptable to clinicians. Our pilot randomised trial compared cord clamping after 2 minutes and initial neonatal care, if needed, with the cord intact, with clamping within 20 seconds and initial neonatal care after clamping. This study demonstrated feasibility of a large UK randomised trial. Of 135 infants allocated to cord clamping ≥ 2 minutes, 7 (5.2%) died and, of 135 allocated to cord clamping ≤ 20 seconds, 15 (11.1%) died (risk difference –5.9%, 95% confidence interval –12.4% to 0.6%). Of live births, 43 out of 134 (32%) allocated to cord clamping ≥ 2 minutes had intraventricular haemorrhage compared with 47 out of 132 (36%) allocated to cord clamping ≤ 20 seconds (risk difference –3.5%, 95% CI –14.9% to 7.8%). LIMITATIONS: Small sample for the qualitative interviews about preterm birth, single-centre evaluation of neonatal care beside the mother, and a pilot trial. CONCLUSIONS: Our programme of research has improved understanding of parent experiences of very preterm birth, and informed clinical guidelines and the research agenda. Our two-stage consent pathway is recommended for intrapartum clinical research trials. Our pilot trial will contribute to the individual participant data meta-analysis, results of which will guide design of future trials. FUTURE WORK: Research in preterm birth should take account of the top priorities. Further evaluation of neonatal care beside the mother is merited, and future trial of alternative policies for management of cord clamping should take account of the meta-analysis. STUDY REGISTRATION: This study is registered as PROSPERO CRD42012003038 and CRD42013004405. In addition, Current Controlled Trials ISRCTN21456601. FUNDING: This project was funded by the National Institute for Health Research (NIHR) Programme Grants for Applied Research programme and will be published in full in Programme Grants for Applied Research; Vol. 7, No. 8. See the NIHR Journals Library website for further project information

Measuring venous oxygenation using the photoplethysmograph waveform

OBJECTIVE: We investigate the hypothesis that the photoplethysmograph (PPG) waveform can be analyzed to infer regional venous oxygen saturation. METHODS: Fundamental to the successful isolation of the venous saturation is the identification of PPG characteristics that are unique to the peripheral venous system. Two such characteristics have been identified. First, the peripheral venous waveform tends to reflect atrial contraction. Second, ventilation tends to move venous blood preferentially due to the low pressure and high compliance of the venous system. Red (660 nm) and IR (940 nm) PPG waveforms were collected from 10 cardiac surgery patients using an esophageal PPG probe. These waveforms were analyzed using algorithms written in Mathematica. Four time-domain saturation algorithms (ArtSat, VenSat, ArtInstSat, VenInstSat) and four frequency-domain saturation algorithms (RespDC, RespAC, Cardiac, and Harmonic) were applied to the data set. RESULTS: Three of the algorithms for calculating venous saturation (VenSat, VenInstSat, and RespDC) demonstrate significant difference from ArtSat (the conventional time-domain algorithm for measuring arterial saturation) using the Wilcoxon signed-rank test with Bonferroni correction (p < 0.0071). CONCLUSIONS: This work introduces new algorithms for PPG analysis. Three algorithms (VenSat, VenInstSat, and RespDC) succeed in detecting lower saturation blood. The next step is to confirm the accuracy of the measurement by comparing them to a gold standard (i.e., venous blood gas)

The Relationship Between Electrocerebral Activity and Cerebral Fractional Tissue Oxygen Extraction in Preterm Infants

Impaired cerebral oxygen delivery may cause cerebral damage in preterm infants. At lower levels of cerebral perfusion and oxygen concentration, electrocerebral activity is disturbed. The balance between cerebral oxygen delivery and oxygen use can be measured by near-infrared spectroscopy (NIRS), and electrocerebral activity can be measured by amplitude-integrated EEG (aEEG). Our aim was to determine the relationship between regional cerebral tissue oxygen saturation (r(c)SO(2)), fractional tissue oxygen extraction (FTOE), and aEEG. We recorded longitudinal digital aEEG and r(c)SO(2) prospectively in 46 preterm infants (mean GA 29.5 wk, SD 1.7) for 2 hr on the 1st to 5th, 8th, and 15th d after birth. We excluded infants with germinal matrix hemorrhage exceeding grade I and recordings of infants receiving inotropes. FTOE was calculated using transcutaneous arterial oxygen saturation (tcSaO(2)) and r(c)SO(2) values: (tcSaO(2) - r(c)SO(2))/tcSaO(2). aEEG was assessed by calculating the mean values of the 5th, 50th, and 95th centiles of the aEEG amplitudes. The aEEG amplitude centiles changed with increasing GA. FTOE and aEEG amplitude centiles increased significantly with postnatal age. More mature electrocerebral activity was accompanied by increased FTOE. FTOE also increased with increasing postnatal age and decreasing Hb levels. (Pediatr Res 70: 384-388, 2011