Trial · Interventional

TerminatedPhase 2Results postedRegistry data

Merotocin in Mothers With Inadequate Milk Production and Infants Delivered Prematurely

Short name MERMAID

NCTNCT02545127Other id000050

Open at ClinicalTrials.govAsk about this trial

This trial was stopped early.

Reason given at the registry: The trial was prematurely terminated. Termination was not because of safety concerns but due to slow recruitment.

Results were posted for this trial.

Overview

Status: Terminated
Phase: Phase 2
Enrollment: 4 participants (actual)
Sponsor: Ferring Pharmaceuticals · Industry
Design: Randomized · Double masking
Countries: 1 country
United States
Start: 28 May 2021
Primary completion: 11 Nov 2022
Completion: 11 Nov 2022
First posted: 9 Sept 2015 (estimated)
Last update posted: 7 Feb 2024
Conditions: Preterm Delivery · Inadequate Milk Production

Timeline

1 trial · 1 stopped early · 1 with posted results

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

202120222023

Ph 2
MERMAID
NCT02545127
28 May 2021 to 11 Nov 2022
Terminated
Terminated

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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

Interventions

MerotocinDrug
PlaceboDrug

Arms2

Experimental
Merotocin (a selective oxytocin-receptor agonist)
Placebo comparator
Placebo

Primary outcomes1

Outcomes the sponsor listed as primary.

Volume of Mother's Own Milk (MoM)
Time frame · Daily days 1 to 14
Registry description
Measured by weight in grams converted to volume in milliliters (mL)

Secondary outcomes(16)

Time to First Occurrence of Daily Volume of MoM ≥ 500 mL
Time frame · From randomization (Day 1) to Day 14
Registry description
Number of days
Time to First Occurrence of Daily Volume of MoM ≥ 750 mL
Time frame · From randomization (Day 1) to Day 14
Registry description
Number of days
Proportion of Participants With a Daily Volume of MoM ≥ 500 mL
Time frame · Days 1 to 14
Registry description
Measured by weight in grams converted to volume in milliliters (mL)
Proportion of Participants With a Daily Volume of MoM ≥ 750 mL
Time frame · Days 1 to 14
Registry description
Measured by weight in grams converted to volume in milliliters (mL)
Volume of MoM
Time frame · Days 15 to 17
Registry description
Measured by weight in grams converted to volume in milliliters (mL)
Volume of MoM Fed to the Infant
Time frame · Days 1 to 14
Registry description
Measured by weight in grams converted to volume in milliliters (mL)
Volume of Formula/Donor Milk Fed to the Infant
Time frame · Days 1 to 14
Registry description
Measured by weight in grams converted to volume in milliliters (mL)
Merotocin Concentration in Milk
Time frame · Day 3
Merotocin Concentration in Milk
Time frame · Day 10
Change in Infant Body Weight
Time frame · From baseline (Day 1) to Day 14
Frequency of Adverse Events (AEs) in Maternal Participants
Time frame · From Screening (0-144 hours of delivery) up to Day 18
Intensity of AEs in Maternal Participants
Time frame · From Screening (0-144 hours of delivery) up to Day 18
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.
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.
Changes in Routine Safety Laboratory Parameters in Maternal Participants
Time frame · From screening up to Day 15
Proportion of Maternal Participants With Markedly Abnormal Changes in Laboratory Values
Time frame · From screening up to Day 15

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcome· Daily days 1 to 14

Volume of Mother's Own Milk (MoM)

Group	Value
Merotocin (a Selective Oxytocin-receptor Agonist)	not posted
Placebo	not posted

Secondary and other outcome results(7)

Secondary outcome· From randomization (Day 1) to Day 14

Time to First Occurrence of Daily Volume of MoM ≥ 500 mL

Group	Value
Merotocin (a Selective Oxytocin-receptor Agonist)	not posted
Placebo	not posted

Secondary outcome· From randomization (Day 1) to Day 14

Time to First Occurrence of Daily Volume of MoM ≥ 750 mL

Group	Value
Merotocin (a Selective Oxytocin-receptor Agonist)	not posted
Placebo	not posted

Secondary outcome· Days 1 to 14

Proportion of Participants With a Daily Volume of MoM ≥ 500 mL

Group	Value
Merotocin (a Selective Oxytocin-receptor Agonist)	not posted
Placebo	not posted

Secondary outcome· Days 1 to 14

Proportion of Participants With a Daily Volume of MoM ≥ 750 mL

Group	Value
Merotocin (a Selective Oxytocin-receptor Agonist)	not posted
Placebo	not posted

Secondary outcome· Days 15 to 17

Volume of MoM

Group	Value
Merotocin (a Selective Oxytocin-receptor Agonist)	not posted
Placebo	not posted

Secondary outcome· Days 1 to 14

Volume of MoM Fed to the Infant

Group	Value
Merotocin (a Selective Oxytocin-receptor Agonist)	not posted
Placebo	not posted

Secondary outcome· Days 1 to 14

Volume of Formula/Donor Milk Fed to the Infant

Group	Value
Merotocin (a Selective Oxytocin-receptor Agonist)	not posted
Placebo	not posted

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
Group	Deaths	Serious events	Other events
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).	0 / 2	0 / 2	0 / 2
PlaceboPlacebo: Placebo nasal spray, 2 sprays with 1 spray in each nostril administered 6 to 8 times/day (Day 1 to Day 14).	0 / 2	1 / 2	1 / 2

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex: Female
Age: from 18 Years up to 44 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

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

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