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Effectiveness of the newborn behavioral observations (NBO) in the NICU

Effectiveness of early intervention in the neonatal intensive care unit (NICU) using newborn behavioral observations (NBO)

Status
Active, not recruiting
Phases
Unknown
Study type
Unknown
Source
JPRN
Registry ID
JPRN-jRCT1040250086
Enrollment
100
Registered
2025-08-27
Start date
2025-08-22
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infants born before 32 weeks or weighing less than 1500g and their mothers Infant, Very Low Birth Weight

Interventions

Infants born before 32 weeks of gestation or with a birth weight less than 1500g who were admitted to the NICU, and their mothers participate multiple sessions of the Neonatal Behavioral Observations
the Neonatal Behavioral Observations (NBO)

Sponsors

Nagai Yukiyo
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1.This study targets mothers who were admitted or transferred to Nagoya City University Hospital or the Japanese Red Cross Aichi Medical Center Nagoya Daini Hospital between August 18, 2025, and June 30, 2027, and who received postpartum checkups. 2. Among these, infants born at less than 32 weeks of gestation or with a birth weight under 1500g who were admitted or transferred to the NICU at Nagoya City University Hospital or the Japanese Red Cross Aichi Medical Center Nagoya Daini Hospital, along with their mothers, are eligible for recruitment. 3. Written consent must be obtained. 4. The score of the Mother Infant Bonding Scale(MIBS-J) questionnaire, completed around 2 weeks postpartum, must be 3 points or higher.

Exclusion criteria

Exclusion criteria: 1. If multiple usual care or NBO sessions cannot be performed before discharge or transfer from the NICU at Nagoya City University Hospital or the Japanese Red Cross Aichi Medical Center Nagoya Second Hospital. 2. If the interval between routine care or NBO sessions is less than one day 3. If the mother is unable to answer the Japanese questionnaire 4. If the infant dies before discharge from the NICU

Design outcomes

Primary

MeasureTime frame
Change in scores on the Mother Infant Bonding Scale(MIBS) before and after the intervention

Secondary

MeasureTime frame
Change in Edinburgh Postnatal Depression Scale (EPDS) scores and maternal salivary oxytocin levels.

Contacts

Public ContactYukiyo Nagai

Nagoya City University

ynagai390503@gmail.com+81-52-853-8760

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026