A Randomised Controlled Trial of Pasteurised Donor Human Milk as Supplementary Nutrition for Infants Born to Women With Diabetes in Pregnancy.
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 1,444
- 试验地点
- 5
- 主要终点
- Proportion of infants admitted to neonatal unit for management of hypoglycaemia
研究概览
简要总结
PRESENT is a multi-center randomised controlled trial that aims to assess whether access to pasteurized donor human milk as supplementary nutrition in the first five days of life for term infants born to women with diabetes in pregnancy reduces the proportion of infants who are admitted to a neonatal unit for management of hypoglycemia compared with current standard hospital care. The trial will also assess other important outcomes including breastfeeding rates, maternal mental health, and infant cow's milk allergy.
There will be two treatment arms. In the intervention arm, PDHM will be made available to infants from randomisation until day 5 of life. Infants allocated to the control arm will receive care as per local unit policy, including supplemental nutrition as recommended by the treating clinician. After hospital discharge, participants will be asked to complete an electronic questionnaire at 2 & 6 weeks and 6 & 12 months after birth. Questionnaires will assess infant feeding practices, maternal quality of life [including anxiety and depression symptoms and health-related quality of life] along with infant cow's milk allergy symptoms.
详细描述
Diabetes in pregnancy is becoming increasingly common globally, with more than 40 000 infants born to women with gestational diabetes alone in Australia each year. These infants are at a high risk of hypoglycaemia and often require admission to the neonatal intensive care unit (NICU) and frequent blood tests for glucose monitoring. Many lack access to sufficient maternal milk partly due to delayed lactogenesis, leading to reliance on cow's milk formula, which may increase risks of cow's milk allergy, early breastfeeding cessation, and long-term metabolic complications.
Pasteurized Donor Human milk (PDHM) supplementation represents an alternative to infant formula when sufficient mother's own milk is not available. In Australia, donor milk is already in use for more vulnerable populations (those born very preterm or of a very low birth weight). However, PDHM is not currently available for term infants, despite strong clinician and community demand.
Expanding the availability of PDHM to term infants has the potential to improve health outcomes for a much larger proportion of the population, with potential benefits for mothers and infants including a reduction in admissions to neonatal intensive care units, a reduction in cow's milk allergy in infants, and improved maternal mental health and breastfeeding outcomes.
Our project will assess the provision of PDHM as in-hospital supplementation for term infants who would otherwise be given cow's milk formula. This trial will address a significant gap in neonatal care and provide evidence to determine whether broader PDHM use could improve both mothers' and infants' long-term health outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
盲法说明
This study has 2 treatment arms. In the intervention arm, pasteurised donor human milk (PDHM) is provided to infants needing nutritional supplementation for the first 5 days of life, compared to standard hospital care.
Participants will not be blinded to study group allocation, because a key research question concerns the consumer experience of accessing PDHM, including how maternal behaviors differ when receiving PDHM. The idea is that having human milk is a "bridge" to exclusive breast milk feeding, rather than a path to continued formula feeding and shorter breastfeeding duration. Many outcomes, such as maternal mental health, breastfeeding impact of access to PDHM) cannot be assessed in a blinded study. The primary outcome is unlikely to be impacted by lack of clinician blinding.
Outcome assessments (analysis of questionnaire responses, skin prick testing for cow's milk allergy) and statistical analyses will be done by assessors blinded to study group allocation.
入排标准
- 年龄范围
- 0 Hours 至 48 Hours（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Each participant must meet all the following criteria to be enrolled in this trial:
- •Mother is >18 years at the time of consent
- •Mother has diabetes in pregnancy (type 1, type 2 or gestational diabetes)
- •Mother intends to breastfeed for at least 6 weeks at the time of consent.
- •Infant is born at ≥ 37 weeks and weighs > 2.5kg
- •Clinician caring for infant decides that supplementary nutrition (in addition to maternal breast milk) is required within the first 48 hours after birth.
- •Parent/s provide/s a signed and dated informed consent form and has a legally acceptable representative capable of understanding the informed consent document and providing consent on the participant's behalf.
排除标准
- •Mother/infant pairs meeting any of the following criteria will be excluded from the trial:
- •Multiple pregnancy
- •Mother has a condition that precludes maternal breast milk consumption e.g. HIV, receiving chemotherapy
- •Infant has clinically significant congenital abnormality interfering with effective breastfeeding or breast milk consumption (e.g., cleft lip and palate, metabolic disorder) and/or requiring immediate care in a neonatal unit (e.g., congenital heart disease).
- •Infant has received infant formula prior to randomisation.
- •Infant admitted to neonatal intensive care prior to randomisation.
- •More than 48 hours old at the time of recruitment
研究组 & 干预措施
PDHM - Pasteurised donor human milk
All infants in this group will get access to Pasteurised donor human milk (PDHM) as supplementary nutrition. PDHM will be made available to the intervention group from the time of randomisation until day 5 of life. Families will be provided with a sufficient supply of frozen PDHM for home use to ensure an exclusively human milk diet up to day 5 of life if their infant is discharged before day 5. Access to PDHM will cease after 120 hours of life, and the infant will be fed according to standard hospital protocols or as per parent's decision.
干预措施: Dietary Supplement: PDHM Pasteurised Donor Human Milk (Dietary Supplement)
Standard Care
All infants in this group will receive the standard care as per local unit policy, including supplemental nutrition (e.g. infant cow's milk formula or IV fluids) as recommended by the treating clinician
干预措施: Standard care Cow's milk based formula (Other)
结局指标
主要结局
Proportion of infants admitted to neonatal unit for management of hypoglycaemia
时间窗: From birth to 120 hours of life
Proportion of infants in intervention and standard care groups admitted to a neonatal unit for management of hypoglycaemia.
次要结局
- Hospital length of stay (infant)(From birth up to initial hospital discharge, up to 90 days of life)
- Hospital re-admission within 30 days(From birth to 30 days after discharge)
- Proportion of infants requiring IV access for dextrose(From birth to 30 days after hospital discharge)
- Episodes of phlebotomy(From birth up to 120 hours of life)
- Duration of hypoglycaemia (<2.6 mmol/L)(From birth upto 120 hours of life)
- Neonatal unit admission and length of stay (infant)(From birth to initial hospital discharge, up to 90 days of life)
- Breast milk feeding(Breast milk feeding at 120 hours of age (this means received any breast milk in previous 24 hours) and at 2 & 6 weeks and 6 months of age)
- Use of Formula feeding(Infant formula feeding at 120 hours of age (received any infant formula in previous 24 hours), and at 2 & 6 weeks and 6 &12 months of age)
- Maternal mental health in the post-partum period GAD-7(At 6 weeks and 6 months post delivery)
- Maternal mental health in the post-partum period using PHQ-9 survey(At 6 weeks and 6 months post delivery)
- Maternal & Infant Health-related quality of life using AQoL-4D(At 6 weeks and 6 months post delivery)
- Maternal & Infant Health-related quality of life using TANDI(At 6 weeks and 6 months post delivery)
- Infant growth up to 12 months(At 4, 8 and 12 months of age)
- Maternal metabolic health(At 6-8 weeks after delivery)
- Infant cow's milk allergy using Questionnaires(At 6 and 12 months)
- Infant cow's milk allergy using SPT(At 6 and 12 months)
- Infant cow's milk allergy using OFC challenge(At 6 and 12 months)
- Infant antibiotic use in the first 12-months of life(At 6 weeks, 6 and 12 months)
- Proportion of infants hospitalised with an infection in the first year of life(At 6 weeks, 6 and 12 months of age)
- Maternal metabolic health(At pre-birth, 6 and 12 months post delivery)