BreastfeedingMILQ premNCT07908238
Maximising Maternal Milk for Preterm Infant
A study testing Hospital grade double electrical breast milk pump in people with Breastfeeding and Prematurity, run by National Maternity Hospital, Ireland at 3 sites in Ireland.
Trial summary
Maternal milk is the gold standard in infant nutrition, providing significant advantages, in preterm and term infants. Maternal milk plays a major role in reducing the risk of inflammatory bowel disease(NEC) in premature and low birth weight infants as well as improving neurodevelopmental outcomes in this population… Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Breastfeeding, Prematurity
- What is being tested?
- Hospital grade double electrical breast milk pump
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 3 sitesIreland
- Study dates
- 7 Nov 2025to 1 Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- The infant/s are born at the National Maternity Hospital with a gestational age at birth < 33 weeks by best obstetric estimate or with a birth weight of < 1500g; or
- The infant/s are born in another centre with a gestational age at birth < 33 weeks by best obstetric estimate and/or with a birth weight of < 1500g and the mother is admitted to the National Maternity Hospital within 24 hours of delivery
Who cannot join
- Breast milk use in the infant is contraindicated
- There is breast hypoplasia on examination or recent breast surgery affecting ability to produce adequate breast milk
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Ireland3 sites, 2 recruiting
- Not yet recruiting
National Maternity Hospital
Dublin, Co. Dublin, D02YH21
Anna Curley, Consultant Neonatology, 00353, anna.curley@nmh.ie
Anna Curley, Consultant Neonatology, 003531637300, anna.curley@nmh.ie
- Recruiting
National Maternity Hospital
Dublin, Co. Dublin, D02YH21
Anna Curley, Consultant Neonatology, 00353, anna.curley@nmh.ie
Anna Curley, Consultant Neonatology, 003531637300, anna.curley@nmh.ie
- Suspended
National Maternity Hospital
Dublin, Co.Dublin, D02YH21
About this study
Official title: Maximising Initial Lactation Quantities for Preterm Infants (The MILQ Prem Study) Daily Breast Milk Volume in Mothers of Preterm Born at or < 33 Weeks or VLBW 1500gm. Randomized Controlled Trial Comparing Hospital Grade Double Electrical Breast Pump Expression Versus Hand Expression
Maternal milk is the gold standard in infant nutrition, providing significant advantages, in preterm and term infants. Maternal milk plays a major role in reducing the risk of inflammatory bowel disease(NEC) in premature and low birth weight infants as well as improving neurodevelopmental outcomes in this population, In this study the investigators are comparing earlier (from birth rather than 48 hours post delivery) use of an electrical breast pump. Mothers will be selected at random to be in one of two groups: early or later pump use. The investigators will compare milk volumes achieved on day 14 post delivery between the two groups. The investigators will recruit x number of mothers of preterm infants < 33 weeks gestation at birth
Read the detailed description
Evidence suggests that the first two weeks after premature delivery are a critical period for initiation and development of lactation. The process is made more complicated following preterm delivery due to immaturity of mammary glands and absence of sucking by premature infants . Preterm delivery also leads to increased levels of stress and anxiety about breast milk expression, especially during the first days after delivery . All these factors can contribute to low milk volumes and reduced nutritional substrate for babies. Inadequate breast milk production during the first few days after delivery leads to longer duration of parenteral nutrition and increased use of donor milk Donor milk is less effective nutritionally and an expensive resource. In babies where donor milk provides sup optimal nutrition, formula milk is required, and this significantly increases the risk of inflammatory bowel disease in preterm infants Suboptimal milk supply is also associated with prolonged use of central lines, greater rates of sepsis and chronic lung disease and prolongation of hospital stay.
International guidelines for production of expressed breast milk (EBM) for premature infants under 34 weeks' gestation from tertiary-level hospitals in Canada, Australia, and the United Kingdom suggest starting with hand expression of milk ideally within the first 1- 3 hours as a gold standard and if that is not possible within the first six hours after delivery, they recommend switching to a double electrical breast pump after the first 24-48 hours post-delivery. Use of hand expression in the first instance is based on the small volumes of colostrum which are likely to be collected. There is no evidence to say whether hand or electrical pump expression from birth is more effective. Hand expression for seven days from birth has been shown to be less effective than pump expression over the same time period but there have been no published studies to compare hand expression as per international guidelines for 2 days followed by use of the electric pump, to use of electric pump from birth .
Currently in our neonatal unit , the recommendation that mothers start expressing breast milk early after delivery initially expressing by hand and then changing to the electric pump from 48 hours. Earlier use of the electric pump may be more effective than hand expression. In this study, the investigators would like to compare use of the electrical pump on on day 1 rather than waiting for 48 hours and compare milk output by 2 weeks of age in the two groups.
Participants will be randomly assigned to one of these two groups:
- Group A: Mothers will hand-express milk for the first two days post-delivery, followed by the use of a hospital-grade electric pump from day 3.
- Group B: Mothers will begin using a hospital-grade electric pump immediately after delivery, followed by hand expression for 10 minutes for the first two days after delivery, and then continue to use the electric pump alone.
- Conditions
- Breastfeeding, Prematurity
- Being tested
- Hospital grade double electrical breast milk pump
- Keywords
- expressed breast milk, lactation, premature feeding, coming to volume, early pump use
- Medical subject headings
- Breast Feeding, Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hospital grade double electrical breast milk pumpDevice
Also called Breast pump, Electrical breast pump, Hospital grade electrical pump
Mothers assigned to the early pump group will be advised to start pumping using a hospital-grade double electrical breast pump as soon after birth(target within first 6 hours after delivery) follow by hand expression for 10 minutes for the first 48 hours then start using a hospital -grade double electrical breast pump.
| Study group | Role | What they receive |
|---|---|---|
| Early expression group | Active comparator | INTERVENTION:
Mothers assigned to the early pump group will be advised to start pumping using a hospital-grade double electrical breast pump as soon after birth (target will be within first 6 hours after delivery) followed by hand expression for 10 minutes. This will occur for the first 48 hours after delivery and then mothers will start using a hospital -grade double electrical breast pump without additional hand expression. Receives: Device: Hospital grade double electrical breast milk pump |
| Late expression group | Other | CONTROL:
Late pumping group:
Mothers assigned to the late pumping group will be advised to start hand expression for the first 48 hours postpartum, and then start using a hospital-grade double electrical breast pump, as per routine practice. Receives: Device: Hospital grade double electrical breast milk pump |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of women achieving > 500mls expressed breast milk by 14 days' post-partum
Measured: from enrolment to two weeks post delivery
Percentage of women achieving > 500mls by 14 days' post-partum in mothers of preterm infants < 33 weeks gestation and/or 1500 gram
Mothers of preterm infants <33 weeks and /or 1500 gram will randomly assigned to early breast pumping group or late breast pumping group as outlined above , the primary outcome is the achieving of more than 500 ml of breast milk by day 14 post delivery.
Measured: Milk amount from time of enrolment to two weeks post delivery
Secondary outcomes (12)
Parenteral nutrition days
Total days of parenteral nutrition until reaching to full feed
Measured: From the time of enrolment until 6 weeks post menstrual age
Time to full feeds
How many days required to reach full feed
Measured: From date of randomization until reaching fullfeed
Donor milk use
The number of participants who required donor milk from birth until discharge
Measured: From the time of enrolment until 6 weeks post menstrual age
Central line associated blood stream infections
The number of participants with any documented central line infection from birth until discharge from hospital .Catheter-related bloodstream infection Clinical signs of sepsis and positive peripheral blood culture in the absence of an obvious source other than CVC with one of the following:
Positive semiquantitative (>15 CFU) or quantitative (>103 CFU) culture from a part of the catheter with the same organisms isolated peripherally Simultaneous quantitative blood cultures with a ratio of ≥3:1 (CVC vs. peripheral) Time difference of ≤2 hours leading to culture positive between CVC and peripheral cultures.
Central line-associated bloodstream infection is primary bloodstream infection in a patient who had a central line within the 48 hours period before development of infection.
Measured: From the time of enrolment until 6 weeks post menstrual age
Necrotising enterocolitis
The number of participants who had any episode of necrotizing enterocolitis as defined by Modified Bell's staging criteria from enrolment to discharge.
Measured: From the time of enrolment until 6 weeks post menstrual age
Chronic lung disease
Total numbers of days of respiratory support for the participant
Measured: From the time of enrolment until 6 weeks post menstrual age
Late onset sepsis
The number of participants who had any documented late onset sepsis, described as documented infection after 72 hours after birth .
Measured: From the time of enrolment until 6 weeks post menstrual age
Breastfeeding at hospital discharge
The number of participants involved in the study discharged home on breast feeding
Measured: From the time of enrolment until 6 weeks post menstrual age
Death before hospital discharge
The number of participants ,time and cause of death during the study period
Measured: From birth to time and date of death
Duration of hospitalisation
To duration in days of hospital stay from birth until discharge from hospital
Measured: From date of randomization until the date of discharge home
Parental attitudes and experiences (interviews with parents to access and enhance family centre care model)
During study period , we are going to carry out interview with parents on level of education during antenatal period on the use of hospital breast pumping , when and how to access breast pumping device , pain associated with hand expression and breast pumping device . Level of education and support during first weeks after delivery . Added more , we are going to perform eduction sessions to the postnatal and delivery wards staff , NICU staff including Consultants , junior doctors and nursing staff .
Measured: From time of birth to discharge from hospital
Formula milk
The number of participants who used of formula milk at any stage after birth until discharge from hospital
Measured: From the time of enrolment until 6 weeks post menstrual age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2026
- Study start7 Nov 2025
- Primary completion1 Jul 2027 (estimated)
- Study completion1 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BreastfeedingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- (P) Among mothers of infants born at or \< 33 weeks of gestation or with a birth weight \<1500g (I) does the use of a hospital-grade double electrical breast pump as soon as possible after delivery followed by hand expression for 10 minutes, for the first 48 hours post-delivery followed by hospital grade double electrical breast pump (C) compared to routine hand milk expression for the first 48 hours post-delivery followed by hospital-grade double electrical breast pump (O) increase the volume of breast milk produced by mothers (T) by 14 days postpartum
- Masking
- None (open label)
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Maternity Hospital, Ireland
- Sponsor type
- University, hospital or other
- Collaborators
- University College Dublin
- Responsible party
- Principal investigator, Sarah Kasha, National Maternity Hospital, Ireland
- Investigators
- Anna Curley, Consultant Neonatology, Principal investigator, National Maternity HospitalMadeleine Murphy, Consultant Neonatology, Principal investigator, National Maternity Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07908238
- Sponsor's protocol ID
- National Maternity Hospital
- Acronym
- MILQ prem
- Status last verified
- Oct 2026
- First submitted
- 29 Sep 2025
- Last updated
- 2 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD may be shared following publication following reasonable ethically approved request
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Maximising Initial Lactation Quantities for Preterm Infants (The MILQ Prem Study) Daily Breast Milk Volume in Mothers of Preterm Born at or < 33 Weeks or VLBW 1500gm. Randomized Controlled Trial Comparing Hospital Grade Double Electrical Breast Pump Expression Versus Hand Expression
- ClinicalTrials.gov ID
- NCT07908238
- Acronym / sponsor ID
- MILQ prem / National Maternity Hospital
- Conditions
- Breastfeeding, Prematurity
- Keywords
- expressed breast milk, lactation, premature feeding, coming to volume, early pump use
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- National Maternity Hospital, IrelandUniversity, hospital or other
- Collaborators
- University College Dublin
- Study start
- 7 Nov 2025 (actual)
- Primary completion
- 1 Jul 2027 (estimated)
- Study completion
- 1 Sep 2027 (estimated)
- First posted
- 2 Nov 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Maternal milk is the gold standard in infant nutrition, providing significant advantages, in preterm and term infants. Maternal milk plays a major role in reducing the risk of inflammatory bowel disease(NEC) in premature and low birth weight infants as well as improving neurodevelopmental outcomes in this population, In this study the investigators are comparing earlier (from birth rather than 48 hours post delivery) use of an electrical breast pump. Mothers will be selected at random to be in one of two groups: early or later pump use. The investigators will compare milk volumes achieved on day 14 post delivery between the two groups. The investigators will recruit x number of mothers of preterm infants < 33 weeks gestation at birth
Detailed description
Evidence suggests that the first two weeks after premature delivery are a critical period for initiation and development of lactation. The process is made more complicated following preterm delivery due to immaturity of mammary glands and absence of sucking by premature infants . Preterm delivery also leads to increased levels of stress and anxiety about breast milk expression, especially during the first days after delivery . All these factors can contribute to low milk volumes and reduced nutritional substrate for babies. Inadequate breast milk production during the first few days after delivery leads to longer duration of parenteral nutrition and increased use of donor milk Donor milk is less effective nutritionally and an expensive resource. In babies where donor milk provides sup optimal nutrition, formula milk is required, and this significantly increases the risk of inflammatory bowel disease in preterm infants Suboptimal milk supply is also associated with prolonged use of central lines, greater rates of sepsis and chronic lung disease and prolongation of hospital stay.
International guidelines for production of expressed breast milk (EBM) for premature infants under 34 weeks' gestation from tertiary-level hospitals in Canada, Australia, and the United Kingdom suggest starting with hand expression of milk ideally within the first 1- 3 hours as a gold standard and if that is not possible within the first six hours after delivery, they recommend switching to a double electrical breast pump after the first 24-48 hours post-delivery. Use of hand expression in the first instance is based on the small volumes of colostrum which are likely to be collected. There is no evidence to say whether hand or electrical pump expression from birth is more effective. Hand expression for seven days from birth has been shown to be less effective than pump expression over the same time period but there have been no published studies to compare hand expression as per international guidelines for 2 days followed by use of the electric pump, to use of electric pump from birth .
Currently in our neonatal unit , the recommendation that mothers start expressing breast milk early after delivery initially expressing by hand and then changing to the electric pump from 48 hours. Earlier use of the electric pump may be more effective than hand expression. In this study, the investigators would like to compare use of the electrical pump on on day 1 rather than waiting for 48 hours and compare milk output by 2 weeks of age in the two groups.
Participants will be randomly assigned to one of these two groups:
- Group A: Mothers will hand-express milk for the first two days post-delivery, followed by the use of a hospital-grade electric pump from day 3.
- Group B: Mothers will begin using a hospital-grade electric pump immediately after delivery, followed by hand expression for 10 minutes for the first two days after delivery, and then continue to use the electric pump alone.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- (P) Among mothers of infants born at or < 33 weeks of gestation or with a birth weight <1500g (I) does the use of a hospital-grade double electrical breast pump as soon as possible after delivery followed by hand expression for 10 minutes, for the first 48 hours post-delivery followed by hospital grade double electrical breast pump (C) compared to routine hand milk expression for the first 48 hours post-delivery followed by hospital-grade double electrical breast pump (O) increase the volume of breast milk produced by mothers (T) by 14 days postpartum
| Arm | Type | Receives |
|---|---|---|
| Early expression group | Active comparator | Device: Hospital grade double electrical breast milk pumpINTERVENTION: Mothers assigned to the early pump group will be advised to start pumping using a hospital-grade double electrical breast pump as soon after birth (target will be within first 6 hours after delivery) followed by hand expression for 10 minutes. This will occur for the first 48 hours after delivery and then mothers will start using a hospital -grade double electrical breast pump without additional hand expression. |
| Late expression group | Other | Device: Hospital grade double electrical breast milk pumpCONTROL: Late pumping group: Mothers assigned to the late pumping group will be advised to start hand expression for the first 48 hours postpartum, and then start using a hospital-grade double electrical breast pump, as per routine practice. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- The infant/s are born at the National Maternity Hospital with a gestational age at birth < 33 weeks by best obstetric estimate or with a birth weight of < 1500g; or
- The infant/s are born in another centre with a gestational age at birth < 33 weeks by best obstetric estimate and/or with a birth weight of < 1500g and the mother is admitted to the National Maternity Hospital within 24 hours of delivery
Key exclusion criteria (2 listed)
- Breast milk use in the infant is contraindicated
- There is breast hypoplasia on examination or recent breast surgery affecting ability to produce adequate breast milk
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hospital grade double electrical breast milk pumpAlso: Breast pump, Electrical breast pump, Hospital grade electrical pumpMothers assigned to the early pump group will be advised to start pumping using a hospital-grade double electrical breast pump as soon after birth(target within first 6 hours after delivery) follow by hand expression for 10 minutes for the first 48 hours then start using a hospital -grade double electrical breast pump. | Device | Early expression group, Late expression group |
Primary outcome
Percentage of women achieving > 500mls expressed breast milk by 14 days' post-partum
Time frame: from enrolment to two weeks post delivery
Percentage of women achieving > 500mls by 14 days' post-partum in mothers of preterm infants < 33 weeks gestation and/or 1500 gram
Time frame: Milk amount from time of enrolment to two weeks post delivery
Mothers of preterm infants <33 weeks and /or 1500 gram will randomly assigned to early breast pumping group or late breast pumping group as outlined above , the primary outcome is the achieving of more than 500 ml of breast milk by day 14 post delivery.
12 secondary outcomes
Parenteral nutrition days
Time frame: From the time of enrolment until 6 weeks post menstrual age
Time to full feeds
Time frame: From date of randomization until reaching fullfeed
Donor milk use
Time frame: From the time of enrolment until 6 weeks post menstrual age
Central line associated blood stream infections
Time frame: From the time of enrolment until 6 weeks post menstrual age
Necrotising enterocolitis
Time frame: From the time of enrolment until 6 weeks post menstrual age
Chronic lung disease
Time frame: From the time of enrolment until 6 weeks post menstrual age
Late onset sepsis
Time frame: From the time of enrolment until 6 weeks post menstrual age
Breastfeeding at hospital discharge
Time frame: From the time of enrolment until 6 weeks post menstrual age
Death before hospital discharge
Time frame: From birth to time and date of death
Duration of hospitalisation
Time frame: From date of randomization until the date of discharge home
Parental attitudes and experiences (interviews with parents to access and enhance family centre care model)
Time frame: From time of birth to discharge from hospital
Formula milk
Time frame: From the time of enrolment until 6 weeks post menstrual age
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2026.
- Individual participant dataSharing planned: Yes. IPD may be shared following publication following reasonable ethically approved request
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Anna Curley, Consultant Neonatology principal investigator
National Maternity Hospital
Madeleine Murphy, Consultant Neonatology principal investigator
National Maternity Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hospital grade double electrical breast milk pump in people with Breastfeeding and Prematurity, run by National Maternity Hospital, Ireland at 3 sites in Ireland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Anna Curley, Consultant Neonatologist (003531637300, anna.curley@nmh.ie), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of women achieving > 500mls expressed breast milk by 14 days' post-partum (time frame: from enrolment to two weeks post delivery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2026.