An interventional study of Hospital grade double electrical breast milk pump in Breastfeeding and Prematurity, sponsored by National Maternity Hospital, Ireland. Recruiting at 3 sites in Ireland. Open to female participants. Per ClinicalTrials.gov, last updated 2026-11-02.
Sponsored by National Maternity Hospital, Ireland · Not applicable, Interventional, and Treatment
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
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:
1,081 studies on the registry are indexed under Breast Feeding; 217 are open to participants now.
This study's planned enrollment of 160 is above the median of 100 across 844 interventional studies indexed under Breast Feeding.
Browse Breast Feeding studies →National Maternity Hospital, Ireland is the lead sponsor of 3 studies on the registry; 1 is open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Device: Hospital grade double electrical breast milk pump
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.
Device: Hospital grade double electrical breast milk 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.
Also known as: Breast pump, Electrical breast pump, Hospital grade electrical pump
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
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.
Time frame: Milk amount from time of enrolment to two weeks post delivery
Parenteral nutrition days
Total days of parenteral nutrition until reaching to full feed
Time frame: From the time of enrolment until 6 weeks post menstrual age
Time to full feeds
How many days required to reach full feed
Time frame: From date of randomization until reaching fullfeed
Donor milk use
The number of participants who required donor milk from birth until discharge
Time frame: 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.
Time frame: 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.
Time frame: From the time of enrolment until 6 weeks post menstrual age
Chronic lung disease
Total numbers of days of respiratory support for the participant
Time frame: 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 .
Time frame: 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
Time frame: 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
Time frame: From birth to time and date of death
Duration of hospitalisation
To duration in days of hospital stay from birth until discharge from hospital
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)
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 .
Time frame: 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
Time frame: From the time of enrolment until 6 weeks post menstrual age
Not enrolling at this site.
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — IPD may be shared following publication following reasonable ethically approved request
Time frame: 24 months
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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National Maternity Hospital, Ireland