Adults 15 to 55, female only, with Preterm Birth or Injuries. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Number of Participants With a Composite Birth OutcomePrimary· 0-7 days after index birth; vital records, mortality records, and fetal death records
Composite of at least one of: small for gestational (SGA), or low birth weight (LBW) less than 2500 grams, preterm birth (PTB) less than 37 weeks' gestation (obstetric estimate), or perinatal mortality (fetal death at or after 20 weeks of gestation or mortality in the first 7 days of life).
Group
Value
95% CI
Treatment - Participation in Nurse Family Partnership Nurse-Family Partnership
892
Control
430
Number of Participants Whose Child Experienced a Major Injury or Concern for Abuse or NeglectPrimary· within 24 months after index birth; Medicaid claims or hospital discharge data
Composite of at least one health care encounter or mortality associated with International Classification of Diseases (ICD) codes indicating either major injury, or, concern for abuse or neglect for the participant's index child(ren).
Group
Value
95% CI
Treatment - Participation in Nurse Family Partnership Nurse-Family Partnership
901
Control
438
Number of Participants With an Inter-birth Interval of < 21 MonthsPrimary· within 21 months after index birth; vital records
Having a subsequent birth within the first 21 months of the index birth
Group
Value
95% CI
Treatment - Participation in Nurse Family Partnership Nurse-Family Partnership
363
Control
199
Number of Participants With an Infant Born Small for Gestational Age (SGA)Secondary· At index birth; vital records
Infant birth weight below the 10th percentile for infants of the same gestational age
Group
Value
95% CI
Treatment - Participation in Nurse Family Partnership Nurse-Family Partnership
553
Control
265
Number of Participants With an Infant Born Large for Gestational Age (LGA)Secondary· At index birth birth; vital records
Infant birth weight above the 90th percentile for infants of the same gestational age
Group
Value
95% CI
Treatment - Participation in Nurse Family Partnership Nurse-Family Partnership
166
Control
95
Number of Participants With an Infant Born With Low Birth Weight (LBW)Secondary· At index birth; vital records
Number of participants with an infant born with a birth weight of less than 2500 grams.
Group
Value
95% CI
Treatment - Participation in Nurse Family Partnership Nurse-Family Partnership
436
Control
219
Number of Participants With an Infant With Very Low Birth WeightSecondary· At index birth; vital records
Number of participants with an infant born with a birth weight of less than 1500 grams.
Group
Value
95% CI
Treatment - Participation in Nurse Family Partnership Nurse-Family Partnership
78
Control
48
Birth Weight (Continuous)Secondary· At index birth; vital records
A continuous measure of infant birth weight (grams)
Group
Value
95% CI
Treatment - Participation in Nurse Family Partnership Nurse-Family Partnership
3085.2
± 609.6
Control
3095.7
± 38.1
Number of Participants With a Preterm BirthSecondary· At index birth; vital records
Infant born before 37 weeks' gestation (obstetric estimate)
Group
Value
95% CI
Treatment - Participation in Nurse Family Partnership Nurse-Family Partnership
379
Control
190
Number of Participants With an Extremely Preterm BirthSecondary· At index birth; vital records
Number of participants with an infant born before 28 weeks' gestation.
Group
Value
95% CI
Treatment - Participation in Nurse Family Partnership Nurse-Family Partnership
32
Control
16
Gestational Age at BirthSecondary· At index birth; vital records
Gestational age at birth in weeks (continuous)
Group
Value
95% CI
Treatment - Participation in Nurse Family Partnership Nurse-Family Partnership
38.2
± 2.3
Control
38.1
± 2.3
Number of Participants Experiencing Perinatal MortalitySecondary· Within 1 week after index birth; mortality records and fetal death records
Fetal death at or after 20 weeks of gestation or mortality in the first 7 days of life
Group
Value
95% CI
Treatment - Participation in Nurse Family Partnership Nurse-Family Partnership
27
Control
10
Sponsor's own description
This study evaluates the effects of the Nurse Family Partnership (NFP), an established home-visiting program, using a scientifically rigorous individual-level randomized controlled trial. The study will be based in South Carolina, where a Medicaid waiver in combination with a pay-for-success contract will allow expansion of the program to women on Medicaid. The study plans to enroll 4000 low-income, first time mothers and their children into the intervention group, and another 2000 into the control group. The study will evaluate the program's impacts on outcomes using administrative records. This study aims to yield new evidence on the effect of NFP in a modern context, applied to a new population, across a broad range of outcomes, and financed by a novel public-private partnership based on accountability for outcomes.
Publications & conference data
6 peer-reviewed publications reference this trial (live from Europe PMC):
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Harvard School of Public Health (HSPH)
Last refreshed: 12 December 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03360539.