| Protocol ID | NCT04445675 |
| Registration Date | 2020-06-24 |
| Status | Unknown Status |
| Sponsor | Sakarya University |
| Country | Turkey (Türkiye) |
| Industry | not industry |
| Blinding | blinded |
| Center Type | singel-center RCT |
| Scope | national RCT |
| First Patient In | 2020-08-01 |
| Last Patient Out | 2021-01-01 |
| Publication | n |
| Gender % | FEMALE |
| Mean Age | 18 Years - 49 Years |
NCT04445675
Investigation of the Effect of Support Provided for Breastfeeding and the Feeding of Infants' With Breast Milk on Hospitalization Due to Jaundice
| 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 |