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Neonatal Unit Studies

Study

Contacts

GA/BW Criteria

Eligibility

Consent

Links

Daytime: Lisa Mravicich 021897982 or Chris McKinlay 0274725099

After hours: Chris McKinlay 0274725099

<28 weeks

No weight restriction

 

Inclusion:

  • <48 hours
  • Surfactant if given, <12 hours ago
  • Receiving mechanical ventilation via an endotracheal tube OR receiving non-invasive respiratory support including CPAP, nasal IPPV or nasal high flow AND a clinical decision to treat with exogenous surfactant

Exclusion:

  • Previous steroids for prevention of lung disease
  • Infant considered non-viable/not going to be admitted to NNU or likely to transfer to nonparticipating NNU within 24 hours of birth
  • Major congenital anomaly

Written informed consent prior to randomisation.


Randomisation

Databases

Flow Chart

Quick Guide

Consent and Forms

Health Professional Brochure

Protocol

Study Handbook

Daytime: Elizabeth Nevill 021300877

After hours: duty consultant

<31 weeks

Exclusion:

  • Twin to twin transfusion
  • Placental abruption
  • Congenital abnormality 
  • Severe antenatal IUGR
  • En caul delivery
  • Short umbilical cord
If unable to obtain consent antenatally, randomise based on deferred consent with informed, written consent obtained within 24 hours.

Consent Form Deferred

Consent Form Antenatal

Protocol



Daytime: Tanith Alexander 02102466276

After hours: Tanith until 8 pm

32+0 to 35+6 weeks

Inclusion:

  • <24 hours of age
  • Mother intends to breastfeed
  • Insertion of intravenous lines based on clinical need
  • Domicile in Auckland

Exclusion:

  • A particular mode of nutrition is clinically indicated 
  • Congenital abnormality likely to affect growth, body composition or neurodevelopmental outcome
Written informed consent prior to randomisation.Randomisation

Daytime: David Hou 021414888 or Lisa Mravicich 021897982

After hours: duty consultant

35 weeks

Inclusion:

  • <23 hours
  • One or more of the following: Apgar ≤ 5 at 10 mins after birth; OR receiving ongoing resuscitation at 10 mins after birth; OR  on cord blood or arterial/venous blood obtained at < 60 mins after birth,  pH less than 7.00 OR base deficit ≥ 12.0 mmol/L. 
  • Moderate to severe encephalopathy, defined between one and six hrs after birth by: 3 out of 6 modified Sarnat criteria indicating moderate/severe encephalopathy
  • Hypothermia treatment initiated by 6 hrs of age; Study treatment planned to start within 24 hrs after birth 
  • At least one parent ≥ 18 yrs old
  • Anticipated ability to collect primary endpoint at 2 yrs

Exclusion:

  • Severe IUGR (birth weight <1800 g) 
  • Suspected major chromosomal or congenital anomalies
  • HC <3rd centile below mean for GA & gender
  • Imminent withdrawal of care is being planned
Written informed consent prior to randomisation. Where this cannot be obtained in time to allow randomisation by 23 hours of age, telephone parental consent is acceptable, with signed consent obtained as soon as feasible. 

Randomisation

Protocol

Consent Form

Drug Administration Guide

Daytime: Lisa Mravicich 021897982 or Chris McKinlay 0274725099

After hours: Chris McKinlay 0274725099


32 weeks

Inclusion:

  • <8 weeks old

Exclusion:

  • Previous exposure to paracetamol or ibuprofen
  • Chronic disease associated with limited life expectancy (<6 years)
  • Likely to leave NZ in first 6 years
Written informed consent prior to randomisation.

Daytime: Lisa Mravicich 021897982 or Chris McKinlay 0274725099

After hours: Chris McKinlay 0274725099


34+0 to 36+6 weeks

Inclusion:

  • <72 hours

Exclusion:

  • Major congenital abnormality
  • Minor congenital abnormality likely to affect respiration, growth or development
  • Previous caffeine treatment
  • Renal or hepatic impairment
  • Tachyarrhythmia
  • Seizures
  • Hypoxic ischaemic encephalopathy
  • Residing outside of the Auckland DHB regions

Written informed consent prior to randomisation.



Randomisation

Databases

Consent Form

Parent Brochure

Health Professional Brochure

Standard Operating Procedures

Trial Handbook inpatient

Protocol

Date calculator

Daytime: Lisa Mravicich 021897982 or Chris McKinlay 0274725099

After hours: Chris McKinlay 0274725099


COMING SOONWritten informed consent prior to randomisation.

Protocol

Video


Daytime: Lisa Mravicich 021897982 or Chris McKinlay 0274725099

After hours: Chris McKinlay 0274725099

35 weeksCOMING SOONWritten informed consent prior to randomisation.


Publications  

2019

  • Manzoni P, Militello MA, Rizzollo S, Tavella E, Messina A, Pieretto M et al (including Meyer M). Is lactoferrin more effective in reducing late-onset sepsis in preterm neonates fed formula than in those receiving mother's own milk? Secondary analyses of two multicenter randomized controlled trials. Am J Perinatol. 2019; 36(S 02):S120-S125.

  • Judd AL, Beck KL, McKinlay CJD, Jackson A, Conlon CA. Validation of a complementary food frequency questionnaire to assess infant nutrient intake. Maternal & Child Nutrition. 2019; 2019:e12879.
  • Cloete E, Gentles TL, Webster DR, Davidkova S, Dixon LA, Alsweiler JM, Bloomfield F, Pulse Oximetry Screening Steering Committee (Including Ardern J and McKinlay CJD). Pulse oximetry screening in a midwifery-led maternity setting with high antenatal detection of congenital heart disease. Acta Paediatr. 2019; DOI: 10.1111/apa.14934
  • Bradford BF, Cronin RS, McCowan LE, McKinlay CJ, Mitchell EA, Thompson JMD. Association between maternally perceived quality and pattern of fetal movements and late stillbirth. Scientific Reports. 2019;9:9815.
  • Manley BJ, McKinlay CJD. Antenatal and postnatal corticosteroids: Knowledge gaps and research priorities. Semin Fetal Neonatal Med. 2019; doi: 10.1016/j.siny.2019.05.006

  • BurakevychN, McKinlay CJD, Harris DL. Alsweiler JM, Harding JE. Factors influencing glycaemic stability after neonatal hypoglycaemia and relationship to neurodevelopmental outcome. Scientific Reports. 2019; doi: 10.1038/s41598-019-44609-1

  • McKinlay CJD, Manley BJ. Antenatal and postnatal corticosteroids: a swinging pendulum. Semin Fetal Neonatal Med. 2019; doi: 10.1016/j.siny.2019.05.007.

  • Meyer MP, Nevill E. Optimizing cord clamping in preterm infants: One strategy does not fit all. Front Pediatr. 2019;7:46. 

  • Okesene-Gafa KA, Taylor RS, Li M, McKinlay CJD, Rush EC, Wall CR, Wilson J, Taylor R, Thompson JM, Crowther CA, McCowan LE. Dietary intervention and or probiotics for pregnant women with obesity: The Healthy Mums and Babies randomized controlled trial. Am J Obst Gynecol. 2019; doi.org/10.1016/j.ajog.2019.03.003

  • Shah R, Harding JE, Brown J, McKinlay CJD. Neonatal glycaemia and neurodevelopmental outcomes: a systematic review and meta-analysis. Neonatology. 2019;115:116–26. 
  • Cartwright RD, Crowther CA, Anderson PJ, Harding JE, Doyle LW, McKinlay CJD. Association of fetal growth restriction with neurocognitive function after repeated antenatal betamethasone treatment vs placebo: Secondary analysis of the ACTORDS randomized clinical trial. JAMA Network Open. 2019;2(2):e187636. 

  • Griffith RJ, Harding JE, McKinlay CJD, Wouldes TA, Harris D, Alsweiler JM, for the CHYLD Study Team. Maternal glycemic control in diabetic pregnancies and neurodevelopmental outcomes in preschool aged children. A prospective cohort study. Early Human Dev. 2019;130:101-108.

2018

  • Mildenhall LFJ, Isayama T. What to do if A + B doesn't work. Semin Fetal Neonatal Med. 2018;23(5):355-360.

  • Battin MR, McKinlay CJD. How do neonatal units within ANZNN manage infants with severe chronic lung disease still requiring major respiratory support at term? J Paed Child Health; 2018; doi:10.1111/jpc.14261.

  • Shah R, McKinlay CJD, Harding JE. Neonatal hypoglycemia: continuous glucose monitoring. Curr Opin Pediatr. 2018; DOI: 10.1097/mop.0000000000000592.

  • Mazahery H, von Hurst PR, McKinlay CJD, Cormack BE, Conlon CA. Air displacement plethysmography (Pea Pod) in full-term and pre-term infants: a comprehensive review of accuracy, reproducibility, and practical challenges. Matern Health Neonatol Perinatol. 2018;4(1):12.
  • Culliney K, McCowan LME, Okesene-Gafa K, Murphy R, Rowan J, Taylor RS, McKinlay CJD. Accuracy of point-of-care HbA1c testing in pregnant women. Aust NZ J Obstet Gynecol. 2018; DOI: 10.1111/ajo.12786.
  • Cartwright RD, Harding JE, Crowther CA, Cutfield WS, Battin MR, Dalziel SR, McKinlay CJD. Repeat antenatal betamethasone and cardiometabolic outcomes. Pediatrics. 2018;142(1):e20180522.

  • Manzoni P, Garcia Sanchez R, Meyer M  et al. Exposure to gastric acid inhibitors increases the risk of infections in preterm VLBW infants but concomitant administration of lactoferrin counteracts this effect. J Pediatr 2018;193:62-67.

  • Meyer MP, Nevill E, Wong MM. Provision of respiratory support compared to no respiratory support before cord clamping for preterm infants. Cochrane Database Syst Rev. 2018;Issue 3. Art. No.: CD012491. DOI: 10.1002/14651858.CD012491.pub2.

  • Bloomfield FH, Harding JE, Meyer MP,  Alsweiler JM, Jiang Y, Wall CR, Alexander T, on behalf of the DIAMOND Study Group. The DIAMOND trial – DIfferent Approaches to MOderate & late preterm Nutrition: Determinants of feed tolerance, body composition and development: protocol of a randomised trial. BMC Pediatrics 2018; 18: 220.

  • McKenzie L, Webber J, Aickin R, Considine J, Lawson A, Mildenhall L, Nation K, Nicholson T, Nuthall G, Scott T, Stuart M. Twenty-one years of saving lives: The New Zealand Resuscitation Council. NZ Med J. 2018 Jun 22;131(1477):9-11.
  • Aldabbagh A, Webb R, Mildenhall L, Best E. Neonatal meningococcal disease. J Paediatr Child Health. 2018;54(6):692-694.
  • Meyer MP, LS Owen, A Te Pas. Use of heated humidified gases for early stabilization of preterm infants: a meta-analysis. Front Pediatr. 2018;DOI.org/10.3389/fped.2018.00319 

2017

  • Bradford BF, Thompson JMD, Heazell AEP, McCowan LME, McKinlay CJD. Understanding the associations and significance of fetal movements in overweight or obese pregnant women: a systematic review. Acta Obstet Gynecol Scand. 2017;97(1):13-24.
  • Brown J, Alwan NA, West J, Brown S, McKinlay CJD, Farrar D, Crowther CA. Lifestyle interventions for the treatment of women with gestational diabetes. Cochrane Database Sys Rev. 2017; Issue 5. Art. No.: CD011970. DOI: 10.1002/14651858.CD011970.pub2.
  • McKinlay CJD, Cutfield WS, Battin MR, Dalziel SR, Crowther CA, Harding JE. Mid-childhood bone mass after repeat antenatal glucocorticoids: a randomized trial. Paediatrics. 2017;139(5):e20164250.

  • Meyer MP, Alexander T. Reduction in necrotizing enterocolitis and improved outcomes in preterm infants following routine supplementation with Lactobacillus GG in combination with bovine lactoferrin. J Neonatal Perinatal Med. 2017;10(3):249-255.

  • Liley HG, Mildenhall L, Morley P, Australian New Zealand Committee on Resuscitation. Australian and New Zealand Committee on Resuscitation Neonatal Resuscitation guidelines 2016.J Paediatr Child Health. 2017;53(7):621-627. 

  • Mildenhall LFJ. Resuscitation of the newborn. Anaesthesia & Intensive Care Medicine. 2017;18(2):99-105.

  • Harding JE, Harris DL, Hegarty JE, Alsweiler JM, McKinlay CJD. An emerging evidence base for the management of neonatal hypoglycaemia. Early Hum Dev. 2017;108:61.

  • Rajput N, McKinlay CJD, Purdie G, Filipovska J, Battin M, Patel H, Tuohy P. Community-based screening to detect school readiness problems in very preterm children. J Paed Child Health. 2017;54(3):238-246.

  • McKinlay CJ, Alsweiler J, Anstice N, Burakevych N, Chakraborty A, Chase JG, Gamble G, Harris D, Jacobs R, Jiang Y, Paudel N, San Diego R, Thompson B, Wouldes T, Harding J. Association of neonatal glycemia with neurodevelopmental outcomes at 4.5 years. JAMA Pediatr. 2017;171(10):1-12.

2016

  • Riviere D, McKinlay CJD, Bloomfield FH. Adaptation for life after birth: a review of neonatal physiology. Anaesthesia Intensive Care Medicine; 2016;18(2):59-67.
  • Okesene-Gafa K, Li M, Taylor RS, Thompson JMD, Crowther CA, McKinlay CJD, McCowan LME. A randomised controlled demonstration trial of multifaceted nutritional intervention and or probiotics: the healthy mums and babies (HUMBA) trial. BMC Pregnancy Childbirth. 2016;16(1):373.
  • Crowther CA, Anderson PJ, McKinlay CJD, Harding JE, Ashwood PJ, Haslam RR, Robinson JS, Doyle LW, for the ACTORDS Follow Up Group. Mid-childhood outcomes of repeat antenatal corticosteroids: a randomized controlled trial. Pediatrics. 2016;138(4):pii;e20160947.

  • Mank A, van Zanten HA, Meyer MP, Pauws S, Lopiore E, te Pas AB. Hypothermia in preterm infants in the first hours after birth: occurrence, course and risk factors. PLoS One. 2016; 11(11): e0164817.

  • Anderson NH, Sadler LC, McKinlay CJD, McCowan LME. INTERGROWTH 21st versus customized birthweight standards for identification of perinatal mortality and morbidity. Am J Obstet Gynecol. 2016; 214(4)590.e.7.

  • Burakevych N, McKinlay CJ, Alsweiler JM, Wouldes TA, Harding JE. Pre-school screening for developmental and emotional health: comparison with neurodevelopmental assessment. J Paediatr Child Health. 2016;52(6):600-7.

2015

  • McKinlay CJD, Cutfield WS, Battin MR, Dalziel SR, Crowther CA, Harding JE. Cardiovascular risk factors in children after repeat doses of antenatal glucocorticoids: an RCT. Pediatrics. 2015;135(2):e405-15.
  • Meyer MP, Hou D, Ishrar N, Stoppelenburg-Dito IM, tePas AB. The effect of initial respiratory support with cold dry gas versus heated humidified gas on admission temperature of preterm infants. J Pediatr  2015;166:245-250.

  • Nevill E, Meyer MP. Effect of delayed cord clamping on breathing and transition at birth in very preterm infants.  Early Hum Dev. 2015;91:407-11.
  • Wyllie J, Perlman JM, Kattwinkel J, Wyckoff MH, Aziz K, Guinsburg R, Kim HS, Liley HG, Mildenhall L, Simon WM, Szyld E, Tamura M, Velaphi S; Neonatal Resuscitation Chapter Collaborators.Resuscitation. Part 7: Neonatal resuscitation: 2015 International Consensus on Cardiopulmonary Resuscitation and Emergency Cardiovascular Care Science with Treatment Recommendations. 2015 Oct;95:e169-201. 
  • McKinlay CJD, Alsweiler JA, Ansell JM, Anstice NS, Chase JG, Gamble GD, Harris DL, Jacob RJ, Jiang Y, Paudel N, Signal M, Thompson B, Wouldes TA, Yu TY, Harding JE, for the CHYLD Study Group. Neonatal glycemia and neurodevelopmental outcomes at two years. N Engl J Med. 2015;373:1507-18.
  • Burakevych N, McKinlay CJ, Alsweiler JM, Harding JE, CHYLD Study Team. Accuracy of caregivers' recall of hospital admissions: implications for research. Acta Paediatr. 2015;104(11):1199-204.
  • Crowther CA, McKinlay CJD, Middleton P, Harding JE. Repeat doses of prenatal corticosteroids for women at risk of preterm birth for improving neonatal health outcomes. Cochrane Database Sys Rev. 2015; Issue 7. Art. No.: CD003935. DOI: 10.1002/14651858.CD003935.pub4.

2014

  • Darlow BA, Marschner SL, Donoghoe M, Battin MR, Broadbent RS, Elder MJ, Hewson MP, Meyer MP, Ghadge A, Graham P, McNeill NJ, Kuschel CA, Tarnow-Mordi WO. Benefits Of Oxygen Saturation Targeting-New Zealand (BOOST-NZ) Collaborative Group. Randomized controlled trial of oxygen saturation targets in very preterm infants: two year outcomes. J Pediatr. 2014; pii: S0022-3476(14)00023-7. doi: 10.1016/j.jpeds.2014.01.017.
  • Manzoni P, Meyer M, Stolfi I, Rinaldi M, Cattani S, Pugni L, Romeo MG, Messner H, Decembrino L, Laforgia N, Vagnarelli F, Memo L, Bordignon L, Maule M, Gallo E, Mostert M, Quercia M, Bollani L, Pedicino R, Renzullo L, Betta P, Ferrari F, Alexander T, Magaldi R, Farina D, Mosca F, Stronati M. Bovine lactoferrin supplementation for prevention of necrotizing enterocolitis in very-low-birth-weight neonates: a randomized clinical trial. Early Hum Dev 2014;90 Suppl 1:S60-5. doi: 10.1016/S0378-3782(14)70020-9. 
  • Meyer MP. Retinopathy of prematurity: etiology and risk factors. Int J Medical Biological Frontiers 2014; 20:195-225. 

2013

  • Meyer MP. Bronchopulmonary dysplasia and erythropoietin. Neonatology 2013;103:123.
  • Bushell T, McHugh C, Meyer MP. A comparison of two nasal continuous positive airway pressure interfaces: a randomized crossover study. J Neonatal Perinatal Med. 2013;6:53-59.
  • Meyer M, Manzoni P. Lactobacillus GG as probiotic for prevention of necrotizing enterocolitis or late onset sepsis in preterm infants: an updated meta-analysis. Early Hum Dev  2013;89s1:S84.
  • The BOOST II United Kingdom, Australia, and New Zealand Collaborative Groups Stenson BJ, Tarnow-Mordi WO, Darlow BA, Simes J, Juszczak E, Askie L, Battin M, Bowler U, Broadbent R, Cairns P, Davis PG, Desphande S, Donoghoe M, Doyle LW, Fleck B, Ghadge A, Hague W, Halliday H, Hewson M, King A, Kirby A, Marlow N, Meyer M, Morley C, Simmer K, Tin W, Wardle SP, Brocklehurst P. Oxygen saturation and outcomes in preterm infants N Engl J Med. 2013; 368:2094-104. 
  • Dargaville PA, Copnell B, Mills JF, Haron I, Lee JK, Tingay DG, Rohana J, Mildenhall LF, Jeng MJ, Narayanan A, Battin MR, Kuschel CA, Sadowsky JL, Patel H, Kilburn CJ, Carlin JB, Morley CJ, LessMAS Trial Study Group. Fluid recovery during lung lavage in meconium aspiration syndrome. Acta Paediatr. 2013 Feb;102(2):e90-3.
  • Mildenhall LF, Huynh TK. Factors modulating effective chest compressions in the neonatal period. Semin Fetal Neonatal Med. 2013;18(6):352-6.

2012

  • Meyer MP, Mildenhall L. Delayed cord clamping and blood flow in the superior vena cava in preterm infants: an observational study. Arch Dis Child Fetal Neonatal. 2012;97:F484-F486. 
  • Meyer MP, Manzoni P. Lactobacillus GG for preterm infants. Arch Dis Child Fetal Neonatal. 2012;97:1 F70-F74.  
  • Shearman AD, Hou D, Dunster KR, Jardine L. Heating of gases during neonatal resuscitation: a bench study. Resuscitation. 2012 Mar;83(3):369-73. 
  • Hou D, Shetty U, Phillips M, Gray PH. Cerebellar haemorrhage in the extremely preterm infant. J Paediatr Child Health. 2012 Apr;48(4):350-5.

Wiki page owner: Dr Chris McKinlay, c.mckinlay@auckland.ac.nz

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