Currently Recruiting

Several clinical trials are currently recruiting New Zealand mothers and babies.

Preconception Trials

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FIXX Study

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.

Status: Recruiting

Sites: Auckland, Hamilton, Wellington, Christchurch

ANZCTR number: ACTRN12619001003167

Contact: [email protected]

Pregnancy Trials

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OBLIGE Trial

Comparing two methods of starting an induction of labour in pregnant women (balloon at home versus hormone gel in hospital) to assess chance of vaginal birth

The induction of labour rate in New Zealand is high. Mechanical methods of induction in hospital are safe and effective. However, most women in New Zealand have induction using pharmacological methods. Trials are needed to determine the safety and effectiveness of outpatient induction with balloon catheter. Outpatient balloon induction has the potential to give women more choice and improve satisfaction, and to save on health care costs, while maintaining safe outcomes for mothers and their babies.

This trial aims to compare two management protocols for initial management of induction of labour. To demonstrate safety, clinical effectiveness and cost effectiveness for mothers and babies who are allowed to go home after commencing a balloon induction, versus remaining in hospital after commencing a prostaglandin induction.

If outpatient balloon induction is found to be as safe and effective as inpatient prostaglandin induction in low-risk women, then district health boards can incorporate this protocol into their clinical guidelines. Moreover, this evidence-based recommendation can be added to the Auckland Consensus Guideline (2014) which will hopefully become a national guideline following broad consultation, enabling consistency of practice across the country.

Status: Recruiting

Sites: Auckland, Dunedin, Hawke's Bay, Hutt Valley, North Shore, Taranaki, Tauranga, Waikato, Waitemata, Waitakere, Wellington, Whakatāne

ANZCTR number: ACTRN12616000739415

Contact: [email protected]

Preterm Infant Trials

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DIAMOND Trial

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.

Status: Recruiting

Sites: Auckland, Middlemore, North Shore, Waitakere, Palmerston North

ANZCTR number: ACTRN12616001199404

Contact: [email protected]

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LATTE Dosage Trial

The most effective and best tolerated dose of caffeine to reduce intermittent hypoxaemia

Research has led to improvements in neurodevelopmental outcomes for infants born very preterm, but there has been little research on long-term neurodevelopmental outcomes for infants born late preterm.  In very preterm infants, both apnoea and intermittent hypoxaemia are common and are associated with worse neurodevelopmental outcomes.  Caffeine has been shown to improve intermittent hypoxaemia in very preterm infants, but there are no data to show if this is the case in late preterm infants.  This trial is designed to determine the safest and most effective dose of caffeine in late preterm infants before wider studies to investigate the effects of caffeine on neurodevelopment in this group can be initiated.

Status: Recruiting

Sites: Auckland, Middlemore

ANZCTR number: ACTRN12618001745235

Contact: [email protected]

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Little Eye Drop Study

Microdrop Administration of Phenylephrine and Cyclopentolate Eye Drops in Neonates

This study aims to find out if low dose versus very low dose pupil dilating eye microdrops are effective in premature infants, and if the eye drops are associated with a low risk of harm.

Retinopathy of prematurity (ROP) is a major cause of blindness in babies born before 31 weeks gestational age or with a birth weight less than 1250 g. Because of the risk of permanent blindness, this group of premature infants have routine ROP eye examinations (ROPEE) involving administration of mydriatic (pupil dilating) eye drops.

Phenylephrine with cyclopentolate or tropicamide are the eye drop regimens used, but in neonatal units in Australia and New Zealand there is a wide variety of regimens in use. Regimens vary in concentration, drop volume and frequency of administration.

Mydriatics have been associated with clinically significant cardiovascular, respiratory and gastrointestinal adverse effects, and there is evidence low dose regimens are just as effective. Therefore, it is hoped this trial will provide guidance for clinical practice to help reduce the exposure of excessive doses that some premature infants are receiving.

Status: Recruiting

Sites: Wellington, Christchurch, Dunedin, Invercargill

ANZCTR number: ACTRN12619000795190

Contact: [email protected]

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Neo Gluco Trial

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.

Status: Recruiting

Sites: Auckland, Middlemore

ANZCTR: ACTRN12620000129987

Contact: [email protected]

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PLUSS Trial

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.

Status: Recruiting

Sites: Auckland, Middlemore, Wellington

ANZCTR number: ACTRN12617000322336

Contact: [email protected]

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PROTECT Trial

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.

Status: Recruiting

Sites: Christchurch, Wellington

ANZCTR number: ACTRN12616000405415

Contact: [email protected]

Newborn Infant Trials

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PAEAN Trial

PAEAN – Erythropoietin for hypoxic ischaemic encephalopathy in newborns

A lack of oxygen (hypoxia) or low blood supply (ischaemia) before or during birth can destroy cells in a newborn baby's brain. The damage caused by the lack of oxygen continues for some time afterwards. One way to try to reduce this damage is to induce hypothermia cooling the baby or just the baby's head for hours to days. Erythropoietin (Epo) given in the first week after birth shows promise as a treatment that may also help. This study is to find out
whether Epo plus induced hypothermia (cooling) of near term newborn babies who have suffered from low blood or oxygen supply to the brain at birth reduces death and disability in survivors at two years of age.

The target population is 300 newborn term or near term infants(greater than or equal to 35+0 weeks gestation) with hypoxic ischaemic encephalopathy who are receiving, or planned to receive hypothermia and who are able to be recruited in time to allow study treatment to commence before 24 hours of age.

Status: Recruiting

Sites: Auckland, Christchurch, Middlemore, Waikato,Wellington

ANZCTR number: ACTRN12614000669695

Contact: [email protected]

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PIPPA Tamariki

Paracetamol and Ibuprofen in Primary Prevention of Asthma

Asthma rates in New Zealand are among the highest in the world. Previous research has suggested that paracetamol given in the first year of life may be responsible for up to 22% of later asthma.

To test this hypothesis, investigators plan to randomise 3,922 babies to receive EITHER paracetamol or ibuprofen, as required for the treatment of fever and pain, in their first 12 months of life. They will follow participants up until the age of six years and assess whether the rates of asthma between the two randomised groups are different.

Status: Recruiting

Sites: Auckland, Middlemore, Wellington

ANZCTR number: ACTRN12618000303246

Contact: [email protected] (Wellington), [email protected] (Auckland)