NCT04445675

Investigation of the Effect of Support Provided for Breastfeeding and the Feeding of Infants' With Breast Milk on Hospitalization Due to Jaundice

Extracted Fields (from Registry)
Protocol IDNCT04445675
Registration Date2020-06-24
StatusUnknown Status
SponsorSakarya University
CountryTurkey (Türkiye)
Industrynot industry
Blindingblinded
Center Typesingel-center RCT
Scopenational RCT
First Patient In2020-08-01
Last Patient Out2021-01-01
Publicationn
Gender %FEMALE
Mean Age18 Years - 49 Years
LLM Classifications (Side-by-Side)
Field OPENAI
gpt-4o
Thinking: o3
3414ms / 9951 tok
GLM
glm-5.1
7484ms / 10140 tok
CLAUDE
claude-sonnet-4-20250514
Thinking: claude-opus-4-20250514
6523ms / 11594 tok
Review
rct_type parallel RCT parallel RCT parallel RCT OK
cancer_status non-cancer non-cancer non-cancer OK
non_cancer_spec N/A N/A N/A OK
setting_patient mixed mixed → outpatient → mixed
shaky reasoning
✓ Unanimous Initial: mixed Requery: outpatient — The intervention is focused on breastfeeding support provided during hospital discharge and continued at home, indicating an outpatient setting. Thinking: mixed — Breastfeeding support is delivered while mothers are hospitalized on the postpartum ward and continues after discharge through home/clinic follow-up.
mixed mixed → mixed
shaky reasoning
✓ Unanimous Initial: mixed Requery: mixed — The breastfeeding intervention is initiated while the mother and infant are admitted in the postpartum service (inpatient) and continues after discharge at home with daily phone calls and an outpatient clinic visit (outpatient).
mixed inpatient → outpatient → mixed
shaky reasoning
✓ Unanimous Initial: inpatient Requery: outpatient — The intervention involves breastfeeding education and support in the postpartum service and lactation outpatient clinic, with mothers being supported at home via phone calls after discharge, indicating outpatient care delivery. Thinking: mixed — The intervention is delivered both during postpartum hospital admission (inpatient) and continues at home with phone follow-up after discharge (outpatient).
OK
setting_place hospital hospital hospital OK
feasibility fully powered RCT fully powered RCT fully powered RCT OK
intervention_pharmacologic no no no OK
intervention_chemo_immuno_radio no no no OK
intervention_complementary no no no OK
intervention_device no no no OK
intervention_psychological no no no OK
intervention_complex no no → no
shaky reasoning
✓ Unanimous Initial: no Requery: no — The intervention focuses on a single type, which is breastfeeding support and education, without combining different categories such as pharmacologic or organizational interventions.
no yes → no
shaky reasoning
✓ Unanimous Initial: yes Requery: no — The intervention is a single-modality educational and behavioral support program focused solely on promoting and assisting with breastfeeding, rather than combining distinct components from different categories.
no no → no
shaky reasoning
✓ Unanimous Initial: no Requery: no — The intervention consists solely of breastfeeding support and education - a single behavioral/educational intervention, even though it covers multiple topics and includes practical demonstrations.
OK
intervention_acp no no no OK
intervention_music no no no OK
intervention_screening no no no OK
intervention_palliative no no → no
shaky reasoning
✓ Unanimous Initial: no Requery: no — The intervention focuses on breastfeeding support, not palliative care itself.
no yes → no
shaky reasoning
✓ Unanimous Initial: yes Requery: no — The intervention is breastfeeding support and education for newborn jaundice prevention, which is a distinct clinical intervention and not a palliative care consultation, team referral, or service delivery model.
no no → no
shaky reasoning
✓ Unanimous Initial: no Requery: no — The intervention is breastfeeding support and education to prevent neonatal jaundice, not palliative care consultation or service delivery.
OK
intervention_education yes yes yes OK
intervention_digital no no no OK
intervention_other yes no → yes
shaky reasoning
✓ Unanimous Initial: no Requery: yes — The intervention focuses on breastfeeding support and education, which does not fit into pharmacologic, complementary, device, psychological, or any other specified categories, and falls under educational and nutritional interventions.
yes no
shaky reasoning
✓ Unanimous Initial: no
yes yes → yes
shaky reasoning
✓ Unanimous Initial: yes Requery: yes — This is a breastfeeding education and support intervention which involves teaching feeding techniques, hand expression, and nutritional guidance - none of which fit the specified categories of pharmacologic, device, psychological, digital, screening, palliative, education (this is practical skill-based support rather than educational intervention), complementary, complex, ACP, music, chemo/immuno/radio.
OK
outcome_symptom no no → no
shaky reasoning
✓ Unanimous Initial: no Requery: no — The trial focuses on breastfeeding support to influence hospitalization due to jaundice, not measuring specific symptoms or using symptom assessment scales.
no yes
shaky reasoning
✓ Unanimous Initial: yes
no no → no
shaky reasoning
✓ Unanimous Initial: no Requery: no — The primary and secondary outcomes measure bilirubin levels and hospitalization status, not specific symptoms using validated instruments.
OK
outcome_qol no no no OK
outcome_dignity no no no OK
outcome_cost yes yes → no → yes
shaky reasoning
✗ No consensus Initial: yes Requery: no — The trial focuses on breastfeeding support and its effect on hospitalization due to jaundice, without mentioning cost-related outcomes or healthcare utilization measures. Thinking: yes — The trial tracks rehospitalization due to jaundice, a healthcare utilization outcome.
no no → no
shaky reasoning
✗ No consensus Initial: no Requery: no — The trial focuses on clinical and healthcare utilization outcomes, specifically measuring hospitalization rates due to jaundice and bilirubin levels, without evaluating cost-effectiveness, healthcare costs, or utilizing hospital readmissions or length of stay as a cost proxy.
yes yes → yes → no
shaky reasoning
✗ No consensus Initial: yes Requery: yes — The study measures hospitalization due to jaundice as a primary endpoint, which is a clear healthcare utilization and cost-related outcome as hospital readmissions represent significant healthcare costs. Thinking: no — While the trial measures hospitalization due to jaundice, it's framed as a clinical outcome (preventing hospitalization) rather than as a healthcare utilization cost or economic endpoint.
outcome_other yes yes yes OK
pharmacologic_sub N/A N/A N/A OK
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