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Completed

NCT Number: NCT07534748

Short-term Neonatal and Parental Outcomes in Low- and High-Risk Infants

This study aimed to evaluate the short-term neonatal and parental outcomes in low- and high-risk infants following a single-session family care education intervention. A total of 34 parent-infant dyads were included.

All parents received a structured, family care education during hospitalization. Parental depression, anxiety, care participation, and neonatal pain were assessed on the 10th day of hospitalization and at discharge.

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Key information

Conditions

Risky Baby

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Afyonkarahisar Health Sciences University Hospital

Afyonkarahisar, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

  • Infants diagnosed as neurodevelopmentally at risk.
  • Infants born between 37 and 40 gestational weeks.
  • Infants with a birth weight below 2500 grams.
  • Infants who have been admitted to the neonatal intensive care unit for at least 10 days since birth.

Exclusion criteria

  • Infants whose families declined participation in the study.
  • Infants with congenital anomalies.

Treatment and study plan

Family Care Intervention

Other

A structured, family care education was provided to parents of hospitalized neonates. The session focused on promoting parental involvement in infant care, reducing parental anxiety and depression, and minimizing neonatal pain. The intervention was delivered individually to each parent-infant dyad during hospitalization and included guidance on routine neonatal care, recognizing and responding to infant cues, and supportive strategies for high-risk infants.

Primary outcomes

  1. Parental Care Participation

    Time frame: 1 year

    In this study, the "Care Participation Assessment Scale for Mothers with Infants Hospitalized in the Neonatal Intensive Care Unit" was used to evaluate the level of maternal participation in the care of their infants. The scale consists of 19 items assessing caregiving practices performed by mothers. Each item is scored dichotomously (Yes/No), with "Yes" scored as 1 and "No" as 0. The total score ranges from 0 to 19, with higher scores indicating greater participation in infant care.

  2. Edinburgh Postnatal Depression Scale

    Time frame: 1 year

    In this study, the Edinburgh Postnatal Depression Scale was used to assess postpartum depressive symptoms. The scale consists of 10 items, each scored on a 4-point Likert scale (0-3). The total score ranges from 0 to 30, with higher scores indicating greater severity of depressive symptoms.

  3. State-Trait Anxiety

    Time frame: 1 year

    In this study, the State-Trait Anxiety Inventory was used to assess anxiety levels. The scale consists of two subscales: state anxiety (STAI-S) and trait anxiety (STAI-T), each comprising 20 items. Items are rated on a 4-point Likert scale, and total scores for each subscale range from 20 to 80, with higher scores indicating greater levels of anxiety.

  4. Neonatal Pain

    Time frame: 1 year

    In this study, the Neonatal Infant Pain Scale was used to assess pain in neonates. The scale consists of 6 items evaluating facial expression, cry, breathing patterns, arm and leg movements, and state of arousal. Each item is scored between 0 and 1, except for crying, which is scored between 0 and 2. The total score ranges from 0 to 7, with higher scores indicating greater pain intensity.

Secondary outcomes

  1. Neurological Risk Level

    Time frame: 1 year

    In this study, neurological risk level was assessed using the Dubowitz Neurological Examination. This standardized assessment evaluates neonatal neurological function, including tone, reflexes, movements, and behavioral responses. The total score ranges from 0 to 34, with higher scores indicating better neurological status and lower neurological risk.

Sponsors and collaborators

Lead sponsor

Inonu University

Other

Registry information

Official study title

Short Term Neonatal and Parents Outcomes in Low and High Risk Infants Undergoing Family Care Intervention

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Apr 16, 2026
Registry last updated
Apr 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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