CompletedNot Applicable

Maternal Role in Oral Feed Establishment in Preterm Neonates

Pakistan130 participantsStarted 2022-03-01

Plain-language summary

Hypothesis Preterm babies who receive sensory motor stimulation from their mothers as compared to trained nurses will 1. Start taking oral feed at the same time as compared to control group 2. Take the same amount of milk at the commencement of oral feeding 3. Take milk with equal efficiency 4. Not face more adverse effects

Who can participate

Age range

30 Weeks – 34 Weeks

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * All preterm of gestation age 28 to 34weeks * Haemodynamically stable * Established full Gavage feed * No respiratory distress * No need for respiratory support except LFNC * Do not receive any kind of analgesics Exclusion Criteria: * Syndromic babies /genetic disorders * Haemodynamically unstable babies including IVH (grade III \& IV), hemodynamically significant PDA on treatment, NEC(stage III) * Major malformations * Cleft lip and palate * Anemia requiring blood transfusion

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Transition Time to Full Oral Feeding

Timeframe: Expected time of oral feed establishment

Improvement (Change) in Efficiency in Oral Feed Establishment

Timeframe: For record purpose in this study results, efficacy level was noted as L4 on the following days D1, D2, D3, D5, D7 and D14

•Adverse Outcome Monitoring

Timeframe: Adverse events were noted on D1, D2,D3,D5,D7 and D14

•Adverse Events Monitoring

Timeframe: Adverse events were noted on D1, D2,D3,D5,D7 and D14

Trial details

NCT IDNCT05484726

SponsorFatima Memorial Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-05-01

Results submitted2023-09-15

View on ClinicalTrials.gov More Preterm Birth trials

Plain-language summary

Who can participate

Age range

30 Weeks – 34 Weeks

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Transition Time to Full Oral Feeding

Timeframe: Expected time of oral feed establishment

Improvement (Change) in Efficiency in Oral Feed Establishment

Timeframe: For record purpose in this study results, efficacy level was noted as L4 on the following days D1, D2, D3, D5, D7 and D14

•Adverse Outcome Monitoring

Timeframe: Adverse events were noted on D1, D2,D3,D5,D7 and D14

•Adverse Events Monitoring

Timeframe: Adverse events were noted on D1, D2,D3,D5,D7 and D14