Inadequate Milk Production, Preterm Delivery
Conditions
Keywords
Inadequate Milk Production
Brief summary
Induction and support of lactation in women with preterm delivery and inadequate milk production.
Interventions
DRUGMerotocin
Merotocin nasal spray 400 μg/dose, 2 sprays with 1 spray in each nostril administered 6 to 8 times/day (Day 1 to Day 14).
DRUGPlacebo
Placebo nasal spray, 2 sprays with 1 spray in each nostril administered 6 to 8 times/day (Day 1 to Day 14).
Sponsors
Ferring Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 44 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Volume of Mother's Own Milk (MoM) | Daily days 1 to 14 | Measured by weight in grams converted to volume in milliliters (mL) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to First Occurrence of Daily Volume of MoM ≥ 750 mL | From randomization (Day 1) to Day 14 | Number of days |
| Proportion of Participants With a Daily Volume of MoM ≥ 500 mL | Days 1 to 14 | Measured by weight in grams converted to volume in milliliters (mL) |
| Proportion of Participants With a Daily Volume of MoM ≥ 750 mL | Days 1 to 14 | Measured by weight in grams converted to volume in milliliters (mL) |
| Volume of MoM | Days 15 to 17 | Measured by weight in grams converted to volume in milliliters (mL) |
| Volume of MoM Fed to the Infant | Days 1 to 14 | Measured by weight in grams converted to volume in milliliters (mL) |
| Volume of Formula/Donor Milk Fed to the Infant | Days 1 to 14 | Measured by weight in grams converted to volume in milliliters (mL) |
| Merotocin Concentration in Milk | Day 3 | — |
| Time to First Occurrence of Daily Volume of MoM ≥ 500 mL | From randomization (Day 1) to Day 14 | Number of days |
| Frequency of Adverse Events (AEs) in Maternal Participants | From Screening (0-144 hours of delivery) up to Day 18 | — |
| Intensity of AEs in Maternal Participants | From Screening (0-144 hours of delivery) up to Day 18 | — |
| Frequency of AEs in Infants | From screening until milk expressed Days 1-14 is consumed/discarded or infant discharged from neonatal intensive care unit (NICU), whichever occurs last. | — |
| Intensity of AEs in Infants | From screening until milk expressed Days 1-14 is consumed/discarded or infant discharged from neonatal intensive care unit (NICU), whichever occurs last. | — |
| Changes in Routine Safety Laboratory Parameters in Maternal Participants | From screening up to Day 15 | — |
| Proportion of Maternal Participants With Markedly Abnormal Changes in Laboratory Values | From screening up to Day 15 | — |
| Change in Infant Body Weight | From baseline (Day 1) to Day 14 | — |
Countries
United States
Participant flow
Recruitment details
The trial was performed in 12 investigational sites in the US between May 2021 and November 2022.
Pre-assignment details
In total, 15 participants were screened. Of these, 11 were screening failures and 4 participants were randomized. All the randomized participants were exposed to the investigational medicinal product (IMP): 2 participants to Merotocin and 2 participants to Placebo.
Participants by arm
| Arm | Count |
|---|---|
| Merotocin (a Selective Oxytocin-receptor Agonist) Merotocin: Merotocin nasal spray 400 μg/dose, 2 sprays with 1 spray in each nostril administered 6 to 8 times/day (Day 1 to Day 14). | 2 |
| Placebo Placebo: Placebo nasal spray, 2 sprays with 1 spray in each nostril administered 6 to 8 times/day (Day 1 to Day 14). | 2 |
| Total | 4 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 0 |
Baseline characteristics
| Characteristic | Merotocin (a Selective Oxytocin-receptor Agonist) | Placebo | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 2 Participants | 2 Participants | 4 Participants |
| Age, Continuous | 31 Years STANDARD_DEVIATION 1.4 | 31.5 Years STANDARD_DEVIATION 6.4 | 31.3 Years STANDARD_DEVIATION 3.8 |
| Body Mass Index (BMI) | 27.5 kg/m^2 STANDARD_DEVIATION 2.2 | 31.7 kg/m^2 STANDARD_DEVIATION 0.1 | 29.6 kg/m^2 STANDARD_DEVIATION 2.7 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 1 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 2 Participants | 1 Participants | 3 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 1 Participants | 2 Participants | 3 Participants |
| Region of Enrollment United States | 2 participants | 2 participants | 4 participants |
| Sex: Female, Male Female | 2 Participants | 2 Participants | 4 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 2 | 0 / 2 |
| other Total, other adverse events | 0 / 2 | 1 / 2 |
| serious Total, serious adverse events | 0 / 2 | 1 / 2 |
Outcome results
Primary
Volume of Mother's Own Milk (MoM)
Measured by weight in grams converted to volume in milliliters (mL)
Time frame: Daily days 1 to 14
Population: The trial was prematurely terminated due to slow recruitment. Data (if collected) are not presented in order to protect the privacy of the trial participant(s).
Secondary
Change in Infant Body Weight
Time frame: From baseline (Day 1) to Day 14
Population: The trial was prematurely terminated due to slow recruitment. Data (if collected) are not presented in order to protect the privacy of the trial participant(s).
Secondary
Changes in Routine Safety Laboratory Parameters in Maternal Participants
Time frame: From screening up to Day 15
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Merotocin (a Selective Oxytocin-receptor Agonist) | Changes in Routine Safety Laboratory Parameters in Maternal Participants | 0 Participants |
| Placebo | Changes in Routine Safety Laboratory Parameters in Maternal Participants | 0 Participants |
Secondary
Frequency of Adverse Events (AEs) in Maternal Participants
Time frame: From Screening (0-144 hours of delivery) up to Day 18
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Merotocin (a Selective Oxytocin-receptor Agonist) | Frequency of Adverse Events (AEs) in Maternal Participants | 0 Participants |
| Placebo | Frequency of Adverse Events (AEs) in Maternal Participants | 1 Participants |
Secondary
Frequency of AEs in Infants
Time frame: From screening until milk expressed Days 1-14 is consumed/discarded or infant discharged from neonatal intensive care unit (NICU), whichever occurs last.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Merotocin (a Selective Oxytocin-receptor Agonist) | Frequency of AEs in Infants | 0 Participants |
| Placebo | Frequency of AEs in Infants | 2 Participants |
Secondary
Intensity of AEs in Infants
Time frame: From screening until milk expressed Days 1-14 is consumed/discarded or infant discharged from neonatal intensive care unit (NICU), whichever occurs last.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Merotocin (a Selective Oxytocin-receptor Agonist) | Intensity of AEs in Infants | Mild adverse events | 0 Adverse Events |
| Merotocin (a Selective Oxytocin-receptor Agonist) | Intensity of AEs in Infants | Moderate adverse events | 0 Adverse Events |
| Merotocin (a Selective Oxytocin-receptor Agonist) | Intensity of AEs in Infants | Severe adverse events | 0 Adverse Events |
| Placebo | Intensity of AEs in Infants | Mild adverse events | 2 Adverse Events |
| Placebo | Intensity of AEs in Infants | Moderate adverse events | 10 Adverse Events |
| Placebo | Intensity of AEs in Infants | Severe adverse events | 3 Adverse Events |
Secondary
Intensity of AEs in Maternal Participants
Time frame: From Screening (0-144 hours of delivery) up to Day 18
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Merotocin (a Selective Oxytocin-receptor Agonist) | Intensity of AEs in Maternal Participants | 0 Severe Adverse Events |
| Placebo | Intensity of AEs in Maternal Participants | 2 Severe Adverse Events |
Secondary
Merotocin Concentration in Milk
Time frame: Day 3
Population: The trial was prematurely terminated due to slow recruitment. Data (if collected) are not presented in order to protect the privacy of the trial participant(s).
Secondary
Merotocin Concentration in Milk
Time frame: Day 10
Population: The trial was prematurely terminated due to slow recruitment. Data (if collected) are not presented in order to protect the privacy of the trial participant(s).
Secondary
Proportion of Maternal Participants With Markedly Abnormal Changes in Laboratory Values
Time frame: From screening up to Day 15
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Merotocin (a Selective Oxytocin-receptor Agonist) | Proportion of Maternal Participants With Markedly Abnormal Changes in Laboratory Values | 0 Participants |
| Placebo | Proportion of Maternal Participants With Markedly Abnormal Changes in Laboratory Values | 0 Participants |
Secondary
Proportion of Participants With a Daily Volume of MoM ≥ 500 mL
Measured by weight in grams converted to volume in milliliters (mL)
Time frame: Days 1 to 14
Population: The trial was prematurely terminated due to slow recruitment. Data (if collected) are not presented in order to protect the privacy of the trial participant(s).
Secondary
Proportion of Participants With a Daily Volume of MoM ≥ 750 mL
Measured by weight in grams converted to volume in milliliters (mL)
Time frame: Days 1 to 14
Population: The trial was prematurely terminated due to slow recruitment. Data (if collected) are not presented in order to protect the privacy of the trial participant(s).
Secondary
Time to First Occurrence of Daily Volume of MoM ≥ 500 mL
Number of days
Time frame: From randomization (Day 1) to Day 14
Population: The trial was prematurely terminated due to slow recruitment. Data (if collected) are not presented in order to protect the privacy of the trial participant(s).
Secondary
Time to First Occurrence of Daily Volume of MoM ≥ 750 mL
Number of days
Time frame: From randomization (Day 1) to Day 14
Population: The trial was prematurely terminated due to slow recruitment. Data (if collected) are not presented in order to protect the privacy of the trial participant(s).
Secondary
Volume of Formula/Donor Milk Fed to the Infant
Measured by weight in grams converted to volume in milliliters (mL)
Time frame: Days 1 to 14
Population: The trial was prematurely terminated due to slow recruitment. Data (if collected) are not presented in order to protect the privacy of the trial participant(s).
Secondary
Volume of MoM
Measured by weight in grams converted to volume in milliliters (mL)
Time frame: Days 15 to 17
Population: The trial was prematurely terminated due to slow recruitment. Data (if collected) are not presented in order to protect the privacy of the trial participant(s).
Secondary
Volume of MoM Fed to the Infant
Measured by weight in grams converted to volume in milliliters (mL)
Time frame: Days 1 to 14
Population: The trial was prematurely terminated due to slow recruitment. Data (if collected) are not presented in order to protect the privacy of the trial participant(s).