Breastfeeding, Breastmilk Expression
Conditions
Keywords
breastmilk supply in preterm infant, breastfeeding preterm infants
Brief summary
The goal of this clinical trial is to learn about the effect of breast-pumping frequency on breast milk supply/ volume in mothers of preterm infants. The main question it aims to answer is: \- What effect does pumping frequency have on breast milk supply. Researchers will compare breastmilk supply of mothers who pump every 2 hours to the supply of those who pump every 3 hours to see if there is a difference in the amount of breastmilk they produce. Participants will be assigned to either pump every 2 hours or every 3 hours and record how many milliliters of breastmilk they produce daily for the first 28 days of their baby's life.
Interventions
BEHAVIORALPumping every 2 hours
The intervention will be pumping every 2 hours.
BEHAVIORALbreast pumping every 3 hours
The intervention will be pumping every 3 hours
Sponsors
University of Alabama at Birmingham
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
No minimum to 28 Days
Healthy volunteers
No
Inclusion criteria
* Inborn infants \<32 weeks gestation * Out-born infants transferred to our facility \<48hours of life * Infants \<1500 grams at birth * Infants whose parents/ guardians have provided legal consent for study participation
Exclusion criteria
* Infants with birthing persons' that are severe/critically ill * Birthing persons of infants \<18 years old * Infants with terminal illness or decision to withhold or limit support * infants with major congenital anomalies, chromosomal disorders, or congenital infections
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Volume of expressed breastmilk | From enrollment to 28 days of life | The primary outcome measure will be the volume of expressed breastmilk obtained in mL per day in the group pumping every 2 hours compared the group pumping every 3 hours |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The percentage of donor breast milk feedings | From enrollment to 28 days of life | This outcome will assess the percentage of any enteral feeding that is derived from donor breast milk. |
| The number of days alive on full feedings | From enrollment to 28 days of life | The total number of days the infant received full enteral feeds (≥120 milliliters(mL)/kilogram(kg)/day). |
| The time to full feedings | From enrollment to 28 days of life | The number of days it takes to initially reach full enteral feeds (≥120mL/kg/day) |
| The number of infants with clinical evidence of feeding intolerance | From enrollment to first 28 days after birth | Infants that have enteral feeds withheld, or in other words made "nothing by mouth" (NPO) \> 24 hours for feeding or abdominal issues |
| Number of central line days | In the first 28 days of life | The total number of days the infant maintained any type of central line access. |
| The number of infants receiving any volume of breastmilk at time of discharge | From enrollment to hospital discharge | Infants who are still receiving any volume of expressed breastmilk upon discharge will be identified and noted. |
| The number of infants exclusively feeding breastmilk at discharge | From enrollment to hospital discharge | Whether or not enrolled infants are receiving all their nutrition from their mom's own expressed breastmilk upon discharge will be noted |
| Average change in weight | from birth to 36 weeks' corrected gestational age | Changes in weight measured in grams (g) from birth to 36 weeks corrected gestational age |
| Average change in length | from birth to 36 weeks corrected gestational age | Changes in length measured in centimeters (cm) |
| Average change in head circumference | from birth to 36 weeks' corrected gestational age | Change in head circumference measured in centimeters (cm) |
| The Bayley Scales of Infant and Toddler Development (BSID) | from 18-26 months of age | The Bayley's cognitive component composite score will be assessed and noted. The cognitive composite score is determined by comparing the child's performance to a normative age-matched sample defined by the assessment. They are interpreted as follows: Mean score of 100 (Standard deviation=15) at the 50th percentile signifies mid-average functioning. Scores below 85 (1 Standard deviation below the mean), at the 16th percentile, indicate mild impairment of being 'at risk' of developmental delay. Monitoring is recommended, along with advice to parents on techniques to enhance development or referral to a therapist based on the level of impairment. Score below 70 (2 Standard deviation below the mean), at the second percentile, indicate moderate to severe impairment. In general, scores falling in the lowest 10th percentile indicate developmental delay. |
Countries
United States
Contacts
CONTACTColm Travers, MD
CONTACTFolasade Aderibigbe, MD
Outcome results
None listed