The Fertility, IVF and Intrauterine Insemination trial in couples with uneXplained infertility
The FIIX study is a randomised controlled trial being carried out across New Zealand involving couples with unexplained infertility who are eligible for public funding. They will receive either four intrauterine insemination (IUI) cycles (washed sperm placed into the uterus) or one in vitro fertilisation (IVF) cycle (embryos made in the laboratory by mixing eggs with sperm) to determine if the treatments have similar live birth rates (LBR). The trial will continue to completion of public treatment for these couples (which is two IVF cycles) and compare LBR and cost at the end. The study hypothesis is that for couples with unexplained infertility, (1) four cycles of IUI is comparable to one completed cycle of IVF for LBR and is more cost effective; and (2) four cycles of IUI followed by two cycles of IVF will result in more live births at lower total cost than two cycles of IVF alone.
Sites: Auckland, Hamilton, Wellington, Christchurch
ANZCTR number: ACTRN12619001003167
PROTECT Me: Assessing Antenatal Maternal Melatonin Supplementation in Fetal Growth Restriction to Improve Neurodevelopmental Outcomes. Fetal growth restriction (FGR) complicates over 30 million pregnancies globally. It significantly increases the risk of stillbirth, preterm birth and is a recognised causal pathway to the neurodevelopmental injury underlying subsequent cognitive and behavioural impairment and cerebral palsy. This is the first phase III randomised, placebo-controlled trial assessing the use of melatonin, a cheap and widely available supplement, in pregnancies complicated by early onset FGR to protect the unborn fetal brain and improve subsequent neurodevelopmental outcomes.
Sites: Auckland (more New Zealand sites are currently in set up)
ANZCTR number: ACTRN12617001515381
Corticosteroids before planned caesarean section from 35+0 to 39+6 weeks of pregnancy
In New Zealand, more than 15,000 babies are born by caesarean section (CS) each year and rates continue to rise. Planned CS poses some risk to babies, in particular, the need for admission to the neonatal unit (NNU) for breathing support which means mothers are separated from their baby.
When given to mothers expecting a preterm birth, corticosteroid injections save babies’ lives and improve neonatal and childhood health. Many clinicians therefore now prescribe these injections before a planned CS at or near term even though there has been limited research about this. As well as benefits these injections may lower blood sugar levels in babies and so possibly cause harm. This trial aims to find out whether giving mothers corticosteroid injections before planned CS birth at 35+0 to 39+6 weeks can safely reduce the risk of breathing problems for babies.
Sites: Auckland (more New Zealand sites are currently in set up)
ACTRN number: ACTRN12620000914965p
Preterm Infant Trials
DIfferent Approaches to MOderate & late preterm Nutrition
This trial is designed to investigate the impact of different feeding strategies, all of which are in current use in NZ, on feed tolerance, body composition and on developmental outcome in moderate to late preterm babies, and to determine whether these differ by sex.
Sites: Auckland, Middlemore, North Shore, Waitakere, Palmerston North
ANZCTR number: ACTRN12616001199404
Diazoxide for babies with severe or recurrent low blood glucose: The Neonatal Glucose Care Optimisation (NeoGluCO) Study
This trial is investigating if early treatment of severe or recurrent neonatal hypoglycaemia (low blood glucose) with oral diazoxide reduces time to successful neonatal metabolic transition. This is defined as achieving glucose stability (blood glucose in the target range of 2.6 to 5.0 mmol/L), full enteral bolus feeds, and stopping of intravenous fluids. Investigators hypothesise that early diazoxide therapy will improve glycaemic stability, allowing earlier weaning off intravenous fluids and establishment of full feeds. If effective, such a treatment could have major benefits for neonates with severe or recurrent hypoglycaemia, including reduced length of admission and separation of mother and baby, reduced use of formula and facilitation of earlier establishment of breastfeeding, reduced number of heel pricks for blood glucose testing, and better long-term neurodevelopmental outcomes.
Sites: Auckland, Middlemore
Preventing Chronic Lung Disease in Extremely Preterm Infants Using Surfactant + Steroid
Bronchopulmonary dysplasia (BPD) is a chronic inflammatory lung disease characterised by disordered alveolar and vascular development, most commonly affecting extremely preterm infants exposed to mechanical ventilation and oxygen therapy for respiratory distress syndrome (RDS). BPD is associated with mortality, and adverse long-term pulmonary and neurodevelopmental outcomes. Despite advances in neonatal care including antenatal corticosteroids, exogenous surfactant, and the increasing use of ‘non-invasive’ ventilation, the incidence of BPD is not decreasing. BPD remains the most important pulmonary complication in extremely preterm infants occurring in about 50% of survivors to 36 weeks post menstrual age, with no new therapies shown to prevent it.
The aim of the PLUSS trial is to evaluate the safety and efficacy of early intratracheal corticosteroid (budesonide) combined with exogenous surfactant as the vehicle for distribution compared with exogenous surfactant alone to increase survival without BPD at 36 weeks’ PMA in extremely preterm infants born <28 weeks’ gestation.
Sites: Auckland, Middlemore, Wellington
ANZCTR number: ACTRN12617000322336
IV pentoxifylline as adjunct therapy to improve long-term disability in preterm infants
Very preterm infants are at risk of developing bacterial blood infections (sepsis) and/or bowel inflammation called Necrotizing EnteroColitis (NEC). Both sepsis and NEC cause harmful inflammation, which can lead to brain injury and increase the risk of disability. Currently sepsis and NEC are treated with antibiotics, supportive care and surgery in some NEC cases, however there is no treatment for reducing the harmful inflammation. Small studies have shown that giving Pentoxifylline, a safe and well tolerated drug, as an adjunct therapy to standard of care during sepsis and NEC may reduce mortality in this vulnerable population of infants. The aim of PROTECT study is to determine if Pentoxifylline plus standard treatment of care in babies born less than 29 weeks gestation with sepsis or NEC improves survival without disability.
Sites: Christchurch, Wellington
ANZCTR number: ACTRN12616000405415