Trial · NCT02951130

Milrinone in Congenital Diaphragmatic Hernia

NCT02951130, Phase 2, Completed, NICHD Neonatal Research Network; results first posted 2025-11-06

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. Milrinone in Congenital Diaphragmatic Hernia. Trials, record NCT02951130. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02951130

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Milrinone in Congenital Diaphragmatic Hernia
NCT number: NCT02951130
Status: Completed
Phases: Phase 2
Enrollment: 66 participants, actual
Lead sponsor: NICHD Neonatal Research Network
Conditions: Congenital Diaphragmatic Hernia, Persistent Pulmonary Hypertension of the Newborn, Hypoxemic Respiratory Failure, Pulmonary Hypoplasia
Interventions: Milrinone, Placebo (5% Dextrose)
First posted: 2016-11-01
Last updated: 2025-11-06
Results first posted: 2025-11-06

Source ClinicalTrials.gov

Registered outcomes14

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Oxygenation Response	24 h after initiation of study drug	The primary outcome of this study is change in oxygenation from baseline (prior to study drug infusion) to 24 hours after initiation of study drug infusion. Oxygenation is assessed by oxygenation index (OI = mean airway pressure x oxygen concentration in % / PaO2 in mmHg). Oxygen saturation index (OSI = mean airway pressure x oxygen concentration in % / oxygen saturation in %) values were converted to OI values for this measure. Data are presented as OI at 24 hours minus OI at baseline. A negative value indicates improvement in oxygenation. A positive value indicates deterioration in oxygenation.
Secondary	Oxygenation Response at 48 and 72 h	48 and 72 h after initiation of study drug	Oxygenation index at 48 and 72 h (or OI at the time of initiation of ECMO or immediately prior to death, for infants placed on ECMO or died before these time points)
Secondary	Changes in Estimated Systolic Pulmonary Arterial Pressure on Echocardiogram	Prior to initiation of study drug to between 24 and 72 hours after initiation of study drug	Changes in echocardiogram to assess pulmonary arterial pressure (as defined by protocol) between pre-study drug echocardiogram and echocardiogram obtained between 24 and 72 h after starting the study drug. The outcome will be available only for those infants who have a pre-study drug echocardiogram and a second echocardiogram between 24 and 72 hours after initiation of study drug performed for clinical reasons.
Secondary	Vasoactive Inotrope Score and Systemic Blood Pressure	72 hours after initiation of study drug	Vasoactive Inotrope Score is a quantitative assessment of the degree of therapeutic support required by the patient to maintain adequate perfusion and/or blood pressure.
Secondary	Area Under the Curve for Inspired Oxygen	After initiation of the study drug at 4 time points per day - every 6 hours x 72 hours or discontinuation of study drug (whichever comes first)	Area under the curve for inspired oxygen after initiation of the study drug (inspired oxygen and ventilator data from 4 time points per day - every 6 hours will be recorded to calculate area under the curve)
Secondary	Oxygenation Response to Additional Inotropes or Pulmonary Vasodilators	Through 24 h post study drug initiation	If subsequent to the study drug, any additional inotrope or pulmonary vasodilator is used (such as iNO), we will evaluate the oxygenation response to these agents. If inotropes or vasodilators were used prior to the initiation of study drug, similar values will be recorded. The OI and PaO2/ FiO2 ratio prior to at least 30 min after initiation of the inotrope / vasodilator are recorded. The change in OI and PaO2/ FiO2 ratio in response to these agents is evaluated as a continuous variable and arbitrarily classified into responders, partial responders and non-responders
Secondary	Supplemental Continuous Oxygen	28 days and 56 days postnatal age (or discharge whichever comes first)	The use of supplemental oxygen at 28 d will be used to calculate the incidence of chronic lung disease. Chronic lung disease severity will be classified similar to the BPD classification in preterm infants at \> 32 week gestation.
Secondary	Survival to Discharge Without ECMO	Measured by no ECMO at time of hospital discharge or at the time the infant reaches 120 days of life and remains in the hospital, whichever comes earlier
Secondary	Clinical Status (Pulmonary and Nutritional)	All clinical status measures (as defined by protocol) will be obtained just prior to the infants discharge from the hospital and again at 12 months of age.	Clinical status - pulmonary (use of supplemental oxygen or respiratory medications - diuretics, methylxanthines, steroids, inhaled or nebulized steroids or bronchodilators) and nutritional (weight, length, head circumference, use of anti-reflux medications)
Secondary	Feasibility and Sample Size Calculation to Perform a Definitive Trial (Primary Outcome - Improvement in Survival Without ECMO	From initial recruitment: 16 patients enrolled per month to complete the trial in 4 years

1 to 10 of 14Source ClinicalTrials.gov

See all 14 registered outcomes

Outcomes14

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Units	Measured as
PRIMARY	Oxygenation Response	24 h after initiation of study drug	Change in Oxygenation Index	MEDIAN
SECONDARY	Oxygenation Response at 48 and 72 h	48 and 72 h after initiation of study drug
SECONDARY	Changes in Estimated Systolic Pulmonary Arterial Pressure on Echocardiogram	Prior to initiation of study drug to between 24 and 72 hours after initiation of study drug
SECONDARY	Vasoactive Inotrope Score and Systemic Blood Pressure	72 hours after initiation of study drug
SECONDARY	Area Under the Curve for Inspired Oxygen	After initiation of the study drug at 4 time points per day - every 6 hours x 72 hours or discontinuation of study drug (whichever comes first)
SECONDARY	Oxygenation Response to Additional Inotropes or Pulmonary Vasodilators	Through 24 h post study drug initiation
SECONDARY	Supplemental Continuous Oxygen	28 days and 56 days postnatal age (or discharge whichever comes first)
SECONDARY	Survival to Discharge Without ECMO	Measured by no ECMO at time of hospital discharge or at the time the infant reaches 120 days of life and remains in the hospital, whichever comes earlier
SECONDARY	Clinical Status (Pulmonary and Nutritional)	All clinical status measures (as defined by protocol) will be obtained just prior to the infants discharge from the hospital and again at 12 months of age.
SECONDARY	Feasibility and Sample Size Calculation to Perform a Definitive Trial (Primary Outcome - Improvement in Survival Without ECMO	From initial recruitment: 16 patients enrolled per month to complete the trial in 4 years

1 to 10 of 14Source ClinicalTrials.gov

See all 14 outcomes

Results by group2

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Oxygenation Response	Milrinone		4.2	Inter-Quartile Range -1.5 to 9	Change in Oxygenation Index
Oxygenation Response	5% dextrose (D5W)		2.6	Inter-Quartile Range 0 to 9.6	Change in Oxygenation Index

Source ClinicalTrials.gov

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Milrinone	33
Overall Study	STARTED	5% dextrose (D5W)	33
Overall Study	COMPLETED	Milrinone	32
Overall Study	COMPLETED	5% dextrose (D5W)	32
Overall Study	NOT COMPLETED	Milrinone	1
Overall Study	NOT COMPLETED	5% dextrose (D5W)	1

Source ClinicalTrials.gov

Adverse events14

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Haemorrhage intracranial	Nervous system disorders	Milrinone	1	33	1
other	Haemorrhage intracranial	Nervous system disorders	5% dextrose (D5W)	1	33	1
other	Shock	Vascular disorders	Milrinone	4	33	4
other	Shock	Vascular disorders	5% dextrose (D5W)	1	33	1
other	Neonatal respiratory failure	Respiratory, thoracic and mediastinal disorders	Milrinone	1	33	1
other	Neonatal respiratory failure	Respiratory, thoracic and mediastinal disorders	5% dextrose (D5W)	0	33	0
serious	Shock	Vascular disorders	Milrinone	1	33	1
serious	Shock	Vascular disorders	5% dextrose (D5W)	2	33	2
serious	Neonatal respiratory failure	Respiratory, thoracic and mediastinal disorders	Milrinone	4	33	4
serious	Neonatal respiratory failure	Respiratory, thoracic and mediastinal disorders	5% dextrose (D5W)	2	33	2

1 to 10 of 14Source ClinicalTrials.gov

See all 14 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Milrinone	7	33
Total, all-cause mortality	5% dextrose (D5W)	2	33
Total, other adverse events	Milrinone	5	33
Total, other adverse events	5% dextrose (D5W)	2	33
Total, serious adverse events	Milrinone	5	33
Total, serious adverse events	5% dextrose (D5W)	3	33

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
29209510	DERIVED

Source PubMed

Grants16

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

Project	Title	Principal investigators	Organization	Funder	Fiscal years	Source
UG1HD021364	NICHD Neonatal Research Network Clinical Center - Case Western Reserve University	HIBBS, ANNA MARIA	CASE WESTERN RESERVE UNIVERSITY	EUNICE KENNEDY SHRIVER NATIONAL INSTITUTE OF CHILD HEALTH & HUMAN DEVELOPMENT	2016 to 2025	NIH RePORTER
UG1HD027851	NICHD Neonatal Research Network	PATEL, RAVI MANGAL	EMORY UNIVERSITY	EUNICE KENNEDY SHRIVER NATIONAL INSTITUTE OF CHILD HEALTH & HUMAN DEVELOPMENT	2016 to 2025	NIH RePORTER
UG1HD027853	NICHD Neonatal Research Network -- Cincinnati Clinical Center	MERHAR, STEPHANIE L	CINCINNATI CHILDRENS HOSP MED CTR	EUNICE KENNEDY SHRIVER NATIONAL INSTITUTE OF CHILD HEALTH & HUMAN DEVELOPMENT	2016 to 2025	NIH RePORTER
UG1HD027880	NICHD Neonatal Research Network - Stanford University	CHOCK, VALERIE	STANFORD UNIVERSITY	EUNICE KENNEDY SHRIVER NATIONAL INSTITUTE OF CHILD HEALTH & HUMAN DEVELOPMENT	2016 to 2025	NIH RePORTER
UG1HD034216	NICHD Neonatal Research Network Clinical Center UAB	CARLO FONT, WALDEMAR A.	UNIVERSITY OF ALABAMA AT BIRMINGHAM	EUNICE KENNEDY SHRIVER NATIONAL INSTITUTE OF CHILD HEALTH & HUMAN DEVELOPMENT	2016 to 2025	NIH RePORTER
UG1HD040492	North Carolina Clinical Center	COTTEN, CHARLES MICHAEL; LAUGHON, MATTHEW; MOORE, RYAN THOMAS	DUKE UNIVERSITY	EUNICE KENNEDY SHRIVER NATIONAL INSTITUTE OF CHILD HEALTH & HUMAN DEVELOPMENT	2016 to 2025	NIH RePORTER
UG1HD040689	NICHD COPPERATIVE MULTICENTER NEONATAL RESEARCH NETWORK	WYCKOFF, MYRA HELEN	UT SOUTHWESTERN MEDICAL CENTER	EUNICE KENNEDY SHRIVER NATIONAL INSTITUTE OF CHILD HEALTH & HUMAN DEVELOPMENT	2016 to 2025	NIH RePORTER
UG1HD053089	Eunice Kennedy Shriver NICHD Cooperative Multicenter Neonatal ResearchNetwork	FULLER, JANELL	UNIVERSITY OF NEW MEXICO HEALTH SCIS CTR	EUNICE KENNEDY SHRIVER NATIONAL INSTITUTE OF CHILD HEALTH & HUMAN DEVELOPMENT	2016 to 2025	NIH RePORTER
UG1HD053109	NICHD Cooperative Multicenter Neonatal Research Network	COLAIZY, TARAH TRINITY	UNIVERSITY OF IOWA	EUNICE KENNEDY SHRIVER NATIONAL INSTITUTE OF CHILD HEALTH & HUMAN DEVELOPMENT	2016 to 2025	NIH RePORTER
UG1HD068244	Clinical Center for NICHD/Neonatal Research Network	DEMAURO, SARA BONAMO; EICHENWALD, ERIC C	UNIVERSITY OF PENNSYLVANIA	EUNICE KENNEDY SHRIVER NATIONAL INSTITUTE OF CHILD HEALTH & HUMAN DEVELOPMENT	2016 to 2025	NIH RePORTER

1 to 10 of 16

See all 16 grants

Trial comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Milrinone vs 5% dextrose (D5W): deaths from any cause	Trial comparisons
Milrinone vs 5% dextrose (D5W): serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT02951130

GET https://conductscience.org/api/trials/v1/NCT02951130/registered

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