Clinical trial NCT02545127: Merotocin in Mothers With Inadequate Milk Production and Infants Delivered Prematurely
Official title: A Randomized, Double-blind, Placebo-controlled, Multicenter Trial Exploring the Efficacy and Safety of Intra-nasal Administration of Merotocin in Increasing Milk Production in Maternal Subjects With Preterm Delivery and Inadequate Milk Production
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Preterm Delivery
Inadequate Milk Production
Keywords: Inadequate Milk Production
Lead sponsor: Ferring Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2015-09-09
Enrollment: 4
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 44
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Induction and support of lactation in women with preterm delivery and inadequate milk production.


Eligibility criteria: Inclusion Criteria:

* Delivered at the hospital system associated with the trial center
* Delivered preterm singleton gestational age 24 weeks + 0 days to 34 weeks + 2 days
* Willing to express milk at least 5 times every 24 hours during the observation period and 6 to 8 times every 24 hours during the treatment and post-treatment follow up
* Produced \< 200 mL milk in 24 hours prior to randomization
* Delivered 96 to 192 (+4) hours prior to randomization

Exclusion Criteria:

* Pre-pregnancy body mass index (BMI) \> 50 kg/m\^2
* Mastitis
* History of breast trauma, breast surgery, nipple piercing
* Prolactin-releasing pituitary tumor, history of Sheehan's syndrome, pituitary surgery/radiation therapy
* Pre-pregnancy insulin-dependent diabetes mellitus, polycystic ovarian syndrome. Note: gestational diabetes is allowed (also when requiring the use of insulin for treatment)
* Unstable thyroid disease
* Moderate or severe renal or hepatic impairment
* Mental illness
* Significant nasal congestion or mucous production
* Use of anti-psychotic drugs within past 12 months

Primary outcomes:
measure: Volume of Mother's Own Milk (MoM)
timeFrame: Daily days 1 to 14
Secondary outcomes:
measure: Time to First Occurrence of Daily Volume of MoM ≥ 500 mL
timeFrame: From randomization (Day 1) to Day 14
measure: Time to First Occurrence of Daily Volume of MoM ≥ 750 mL
timeFrame: From randomization (Day 1) to Day 14
measure: Proportion of Participants With a Daily Volume of MoM ≥ 500 mL
timeFrame: Days 1 to 14
measure: Proportion of Participants With a Daily Volume of MoM ≥ 750 mL
timeFrame: Days 1 to 14
measure: Volume of MoM
timeFrame: Days 15 to 17
measure: Volume of MoM Fed to the Infant
timeFrame: Days 1 to 14
measure: Volume of Formula/Donor Milk Fed to the Infant
timeFrame: Days 1 to 14
measure: Merotocin Concentration in Milk
timeFrame: Day 3
measure: Merotocin Concentration in Milk
timeFrame: Day 10
measure: Change in Infant Body Weight
timeFrame: From baseline (Day 1) to Day 14
measure: Frequency of Adverse Events (AEs) in Maternal Participants
timeFrame: From Screening (0-144 hours of delivery) up to Day 18
measure: Intensity of AEs in Maternal Participants
timeFrame: From Screening (0-144 hours of delivery) up to Day 18
measure: Frequency of AEs in Infants
timeFrame: From screening until milk expressed Days 1-14 is consumed/discarded or infant discharged from neonatal intensive care unit (NICU), whichever occurs last.
measure: Intensity of AEs in Infants
timeFrame: From screening until milk expressed Days 1-14 is consumed/discarded or infant discharged from neonatal intensive care unit (NICU), whichever occurs last.
measure: Changes in Routine Safety Laboratory Parameters in Maternal Participants
timeFrame: From screening up to Day 15
measure: Proportion of Maternal Participants With Markedly Abnormal Changes in Laboratory Values
timeFrame: From screening up to Day 15
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Ferring Investigational Site
state: Connecticut
city: South Bend
country: United States
facility: Ferring Investigational Site
state: Indiana
city: Baltimore
country: United States
facility: Ferring Investigational Site
state: Maryland
city: Boston
country: United States
facility: Ferring Investigational Site
state: Massachusetts
city: Valhalla
country: United States
facility: Ferring Investigational Site
state: New York
city: Raleigh
country: United States
facility: Ferring Investigational Site
state: North Carolina
city: Cincinnati
country: United States
facility: Ferring Investigational Site
state: Ohio
city: Charleston
country: United States
facility: Ferring Investigational Site
state: South Carolina
city: Houston
country: United States
facility: Ferring Investigational Site
state: Texas
city: San Antonio
country: United States
facility: Ferring Investigational Site
state: Texas
Study officials:
affiliation: Ferring Pharmaceuticals
name: Global Clinical Compliance
role: STUDY_DIRECTOR
References: